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Trial record 66 of 350 for:    sprains and strains

5% Topical Ibuprofen (IBU) for Ankle Sprain

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ClinicalTrials.gov Identifier: NCT01945034
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankle Injuries
Interventions Drug: Topical IBU twice daily
Drug: Placebo twice daily
Drug: Topical IBU three times daily
Drug: Placebo three times daily
Enrollment 304
Recruitment Details Study was conducted in United States from 08 November 2013 to 19 February 2015.
Pre-assignment Details Out of the 348 screened participants, 304 were randomized and received treatment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Period Title: Overall Study
Started 67 85 152
Completed 66 80 145
Not Completed 1 5 7
Reason Not Completed
Medication Error             0             1             0
Withdrawal by Subject             0             3             1
Other             0             1             3
Lost to Follow-up             0             0             2
Protocol Violation             1             0             1
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined Total
Hide Arm/Group Description Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen. Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days. Total of all reporting groups
Overall Number of Baseline Participants 67 85 152 304
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 85 participants 152 participants 304 participants
31.7  (15.20) 35.2  (14.72) 33.0  (13.90) 33.3  (14.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 85 participants 152 participants 304 participants
Female
34
  50.7%
39
  45.9%
61
  40.1%
134
  44.1%
Male
33
  49.3%
46
  54.1%
91
  59.9%
170
  55.9%
Categorical Pain Severity Rating (PSR)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 85 participants 152 participants 304 participants
Moderate 43 63 102 208
Severe 24 22 50 96
[1]
Measure Description: Participants were assessed by 4-Point category pain severity rating scale. Participants rated their pain upon weight bearing using a four-point scale, as follows: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. All participants had moderate or severe ankle pain upon weight bearing at baseline.
Baseline Ankle Pain upon Weight Bearing   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 67 participants 85 participants 152 participants 304 participants
8.3  (1.25) 8.1  (1.13) 8.4  (1.17) 8.3  (1.18)
[1]
Measure Description: Participants rated their pain on full weight-bearing movement. Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain and this best describes their current pain in the injured ankle. At baseline, participants recorded a value of at least 6 (inclusive) to be eligible to participate in the study.
Baseline Ankle Pain at Rest   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 67 participants 85 participants 152 participants 304 participants
6.2  (1.77) 6.5  (1.48) 6.5  (1.70) 6.4  (1.65)
[1]
Measure Description: Participants rated their pain at rest. PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain and this best describes their current pain in the injured ankle.
Baseline Participant's Global Assessment of Ankle Injury   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 85 participants 152 participants 304 participants
Very Good(1) 0 0 0 0
Good(2) 0 0 7 7
Fair(3) 34 56 77 167
Poor(4) 30 25 55 110
Very Poor(5) 3 4 13 20
[1]
Measure Description: Participants were asked the following question: “Considering all the ways your ankle injury affects you, how are you doing today?” The participant’s response was recorded using a 5-point scale: 1 = Very Good, No symptoms and no limitations of normal activities; 2 = Good, Mild symptoms and no limitation of normal activities; 3 = Fair, Moderate symptoms and limitations of some normal activities; 4 = Poor, Severe symptoms and inability to carry out most normal activities; and 5 = Very Poor, Very severe symptoms which are intolerable and inability to carry out all normal activities.
Baseline Physician Global Assessment of Ankle Injury   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 85 participants 152 participants 304 participants
Normal(0) 0 0 0 0
Very mild(1) 0 0 1 1
Mild(2) 9 28 30 67
Moderate(3) 50 54 101 205
Severe(4) 8 3 20 31
Very severe(5) 0 0 0 0
[1]
Measure Description: The physician assessment of the severity of the ankle injury was based on the participant’s individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and graded using the following 6-point scale: 0 = Normal, No signs or symptoms; 1= Very mild, Very mild signs and symptoms; 2 = Mild, Mild signs and symptoms; 3 = Moderate, Moderate signs and symptoms; 4 = Severe, Severe signs and symptoms; 5 = Very severe, Very severe signs and symptoms.
Baseline Participant Assessment of Normal Function/Activity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 85 participants 152 participants 304 participants
Normal walking/activity and no pain(1) 0 0 0 0
Normal walking/activity with pain(2) 1 4 9 14
Mild restrict walking(3) 16 26 26 68
Moderate restrict walking(4) 43 45 91 179
Severe restrict walking(5) 7 10 26 43
[1]
Measure Description: Participants were asked the following question: “How does your ankle injury affect your walking and normal activity?” The participant’s response was recorded using a 5-point scale: 1=Normal activity and no pain; 2=Normal activity with pain; 3=Mildly restricted walking due to pain and can’t resume normal activities; 4=Moderately restricted walking due to pain and can’t resume normal activities; 5=Severely restricted walking due to pain and can’t resume normal activities. The score ranges from 1-5, with higher scores indicates restricted activity.
1.Primary Outcome
Title Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)
Hide Description PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.
Time Frame Over 3 Days (0-72 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
188.9  (14.81) 173.6  (13.6) 165.9  (10.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 23
Confidence Interval (2-Sided) 95%
-11.49 to 57.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
-24.20 to 39.70
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.436
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.3
Confidence Interval (2-Sided) 95%
-53.87 to 23.30
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)
Hide Description PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
46.9  (5.03) 41.1  (4.62) 42.1  (3.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-6.98 to 16.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-11.90 to 9.82
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.8
Confidence Interval (2-Sided) 95%
-18.91 to 7.32
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)
Hide Description PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
Time Frame 0 to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
44.7  (4.65) 29.4  (4.29) 34.7  (3.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 10
Confidence Interval (2-Sided) 95%
-0.92 to 20.91
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-15.40 to 4.70
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.3
Confidence Interval (2-Sided) 95%
-27.53 to -3.16
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Participant’s Global Assessment of Ankle Injury at Day 3 and 10
Hide Description Participant’s global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Time Frame Baseline, Day 3, 10
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at: Day 3 0.7  (0.09) 0.7  (0.08) 0.6  (0.06)
Change at: Day 10 1.8  (0.09) 1.7  (0.09) 1.6  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.305
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.10 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.261
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.08 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.22 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.08 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.14 to 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.33 to 0.17
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10
Hide Description The physician assessment of the severity of the ankle injury was based on the participant’s individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.
Time Frame Baseline, Day 3, 10
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at: Day 3 0.7  (0.08) 0.7  (0.07) 0.8  (0.06)
Change at: Day 10 1.8  (0.09) 2.0  (0.09) 2.0  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.27 to 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.28 to 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.23 to 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.43 to -0.00
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.25 to 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments p-value <=0.05 for treatment effects
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.08 to 0.41
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points
Hide Description PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.
Time Frame Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.
Arm/Group Title Ibuprofen Twice Daily Ibuprofen Thrice Daily Placebo Combined
Hide Arm/Group Description:
Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
Overall Number of Participants Analyzed 67 85 152
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Change at: At Rest 1 hour Day 1 1.3  (0.19) 0.7  (0.17) 1.2  (0.13)
Change at: Upon Weight Bearing 1 hour Day 1 1.5  (0.20) 1.1  (0.18) 1.4  (0.14)
Change at: At Rest 2 hour Day 1 1.7  (0.22) 1.2  (0.20) 1.5  (0.15)
Change at: Upon Weight Bearing 2 hour Day 1 1.8  (0.23) 1.5  (0.21) 1.8  (0.16)
Change at: At Rest 3 hour Day 1 1.9  (0.23) 1.2  (0.22) 1.6  (0.16)
Change at: Upon Weight Bearing 3 hour Day 1 2.2  (0.25) 1.7  (0.23) 1.9  (0.17)
Change at: At Rest 4 hour Day 1 1.8  (0.24) 1.2  (0.22) 1.5  (0.16)
Change at: Upon Weight Bearing 4 hour Day 1 1.9  (0.25) 1.8  (0.23) 1.7  (0.18)
Change at: At Rest 5 hour Day 1 1.9  (0.24) 1.1  (0.22) 1.4  (0.16)
Upon Weight Bearing: 5 hour Day 1 2.2  (0.26) 1.6  (0.24) 1.7  (0.18)
Change at: At Rest 6 hour Day 1 1.9  (0.24) 1.1  (0.22) 1.2  (0.16)
Change at: Upon Weight Bearing 6 hour Day 1 2.1  (0.25) 1.6  (0.23) 1.5  (0.17)
Change at: At Rest Day 1(PM) 1.8  (0.22) 1.1  (0.20) 1.2  (0.15)
Change at: Upon Weight Bearing Day 1(PM) 2.0  (0.24) 1.6  (0.22) 1.6  (0.17)
Change at: At Rest Day 2(AM) 2.0  (0.22) 1.3  (0.20) 1.6  (0.15)
Change at: Upon Weight Bearing Day 2(AM) 2.0  (0.24) 1.8  (0.22) 1.9  (0.17)
Change at: At Rest Day 2 Mid-day 2.3  (0.23) 1.7  (0.21) 1.8  (0.16)
Change at: Upon Weight Bearing Day 2 Mid-day 2.5  (0.24) 2.1  (0.22) 2.1  (0.17)
Change at: At Rest Day 2(PM) 2.2  (0.23) 1.9  (0.21) 1.8  (0.16)
Change at: Upon Weight Bearing Day 2(PM) 2.4  (0.24) 2.4  (0.22) 2.1  (0.17)
Change at: At Rest Day 3(AM) 2.7  (0.22) 2.0  (0.21) 2.1  (0.16)
Change at: Upon Weight Bearing Day 3(AM) 2.8  (0.25) 2.7  (0.23) 2.5  (0.17)
Change at: At Rest Day 3(AM + 2 hours) 2.8  (0.24) 2.2  (0.22) 2.2  (0.16)
Change at: Upon Weight Bearing Day 3(AM + 2 hours) 2.9  (0.26) 2.9  (0.24) 2.6  (0.18)
Change at: At Rest Day 3 Mid-day 3.0  (0.23) 2.2  (0.22) 2.3  (0.16)
Change at: Upon Weight Bearing Day 3 Mid-day 3.2  (0.26) 2.9  (0.24) 2.7  (0.18)
Change at: At Rest Day 3(PM) 3.0  (0.23) 2.1  (0.22) 2.3  (0.16)
Change at: Upon Weight Bearing Day 3(PM) 3.1  (0.25) 2.8  (0.23) 2.7  (0.18)
Change at: At Rest Day 4(AM) 3.2  (0.23) 2.5  (0.21) 2.6  (0.16)
Change at: Upon Weight Bearing Day 4(AM) 3.4  (0.25) 3.2  (0.23) 3.0  (0.18)
Change at: At Rest Day 4 Mid-day 3.2  (0.25) 2.5  (0.23) 2.5  (0.17)
Change at: Upon Weight Bearing Day 4 Mid-day 3.5  (0.27) 3.3  (0.25) 3.2  (0.19)
Change at: At Rest Day 4(PM) 3.2  (0.24) 2.7  (0.22) 2.5  (0.17)
Change at: Upon Weight Bearing Day 4(PM) 3.4  (0.27) 3.4  (0.25) 3.1  (0.19)
Change at: At Rest Day 5(AM) 3.3  (0.24) 2.8  (0.22) 2.7  (0.17)
Change at: Upon Weight Bearing Day 5(AM) 3.7  (0.27) 3.5  (0.24) 3.3  (0.19)
Change at: At Rest Day 5 Mid-day 3.4  (0.25) 2.9  (0.23) 2.7  (0.17)
Change at: Upon Weight Bearing Day 5 Mid-day 3.7  (0.27) 3.7  (0.25) 3.3  (0.19)
Change at: At Rest Day 5(PM) 3.4  (0.25) 3.0  (0.23) 2.8  (0.17)
Change at: Upon Weight Bearing Day 5(PM) 3.8  (0.28) 3.7  (0.26) 3.5  (0.19)
Change at: At Rest Day 6(AM) 3.5  (0.25) 3.2  (0.23) 3.1  (0.17)
Change at: Upon Weight Bearing Day 6(AM) 3.9  (0.28) 4.0  (0.26) 3.8  (0.20)
Change at: At Rest Day 6 Mid-day 3.5  (0.25) 3.3  (0.23) 3.1  (0.17)
Change at: Upon Weight Bearing Day 6 Mid-day 3.8  (0.28) 4.1  (0.26) 3.7  (0.20)
Change at: At Rest Day 6(PM) 3.6  (0.26) 3.3  (0.24) 2.9  (0.18)
Change at: Upon Weight Bearing Day 6(PM) 3.9  (0.29) 4.2  (0.27) 3.7  (0.20)
Change at: At Rest Day 7(AM) 3.6  (0.25) 3.5  (0.23) 3.1  (0.17)
Change at: Upon Weight Bearing Day 7(AM) 4.2  (0.29) 4.5  (0.27) 3.9  (0.20)
Change at: At Rest Day 7 Mid-day 4.0  (0.25) 3.6  (0.23) 3.2  (0.18)
Change at: Upon Weight Bearing Day 7 Mid-day 4.6  (0.29) 4.5  (0.27) 4.1  (0.20)
Change at: At Rest Day 7(PM) 3.9  (0.25) 3.7  (0.23) 3.4  (0.17)
Change at: Upon Weight Bearing Day 7(PM) 4.5  (0.29) 4.7  (0.27) 4.2  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.38 to 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.88 to -0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.03 to -0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.38 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.71 to 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.89 to 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.40 to 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.85 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.07 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.50 to 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.77 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.90 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.19 to 0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.207
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.83 to 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.30 to -0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.32 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.70 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.08 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.24 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.81 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.23 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.456
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.37 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.42 to 0.68
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.75 to 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.04 to 1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.70 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.33 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.11 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.57 to 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.18 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.12 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.60 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.39 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.07 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.42 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.18 to 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.10 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.749
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.55 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.27 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.16 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.727
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.43 to 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.94 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.16 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.73 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.19 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.858
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.50 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.60 to 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.651
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.76 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.02 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.57 to 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.19 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.21 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.911
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.49 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.305
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.96 to 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.05 to 1.02
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.684
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.39 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.208
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.98 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.304
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.27 to 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.27 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.876
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.67 to 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.10 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 62 Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.940
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.50 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.23 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 64 Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.21 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.26 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 66 Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.74 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 67 Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.13 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 68 Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.48 to 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 69 Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.28 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 70 Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.27 to 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 71 Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.29 to 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 72 Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.73 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 73 Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.19 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 74 Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.763
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.58 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 75 Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.43 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 76 Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-0.10 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 77 Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.38 to 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 78 Hide Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.99 to 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 79 Hide Statistical Analysis 79
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.13 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 80 Hide Statistical Analysis 80
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.69 to 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 81 Hide Statistical Analysis 81
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.47 to -0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 82 Hide Statistical Analysis 82
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.19 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 83 Hide Statistical Analysis 83
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.40 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 84 Hide Statistical Analysis 84
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.92 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 85 Hide Statistical Analysis 85
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.02 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 86 Hide Statistical Analysis 86
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.59 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 87 Hide Statistical Analysis 87
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.25 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 88 Hide Statistical Analysis 88
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.19 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 89 Hide Statistical Analysis 89
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.40 to 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 90 Hide Statistical Analysis 90
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.92 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 91 Hide Statistical Analysis 91
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.10 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 92 Hide Statistical Analysis 92
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.987
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.54 to 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 93 Hide Statistical Analysis 93
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.33 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 94 Hide Statistical Analysis 94
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.31 to 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 95 Hide Statistical Analysis 95
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.47 to 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 96 Hide Statistical Analysis 96
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Ibuprofen Thrice Daily
Comments Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.91 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 97 Hide Statistical Analysis 97
Statistical Analysis Overview Comparison Group Selection Ibuprofen Twice Daily, Placebo Combined
Comments At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANOVA
Comments p-value <=0.05 for treatment effects
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.14 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 98 Hide Statistical Analysis 98
Statistical Analysis Overview Comparison Group Selection Ibuprofen Thrice Daily, Placebo Combined
Comments