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A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain (SDDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912650
Recruitment Status : Completed
First Posted : September 23, 2016
Results First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-surgical Pain Following Extraction of Molar Teeth
Interventions Drug: Ibuprofen 250 mg / Acetaminophen 500 mg
Drug: Ibuprofen 250 mg
Drug: Acetaminophen 650 mg
Drug: Placebo
Enrollment 568
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description Participants received Placebo as a single oral dose caplet during the study of 12 hours. Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study. Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study. Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Period Title: Overall Study
Started 56 172 175 165
Completed 55 172 173 160
Not Completed 1 0 2 5
Reason Not Completed
Withdrawal by Subject             1             0             1             5
Adverse Event             0             0             1             0
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg Total
Hide Arm/Group Description Participants received Placebo as a single oral dose caplet during the study of 12 hours. Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study. Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study. Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study. Total of all reporting groups
Overall Number of Baseline Participants 56 172 175 165 568
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 172 participants 175 participants 165 participants 568 participants
19.6  (3.0) 19.3  (1.8) 19.7  (2.7) 19.4  (2.1) 19.5  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 172 participants 175 participants 165 participants 568 participants
Female
34
  60.7%
102
  59.3%
102
  58.3%
97
  58.8%
335
  59.0%
Male
22
  39.3%
70
  40.7%
73
  41.7%
68
  41.2%
233
  41.0%
1.Primary Outcome
Title Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])
Hide Description Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time Frame 0 to 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (19.0) 34.3  (19.6) 28.9  (20.5) 19.4  (20.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 30.08
Confidence Interval (2-Sided) 95%
24.14 to 36.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.66
Confidence Interval (2-Sided) 95%
1.51 to 9.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.76
Confidence Interval (2-Sided) 95%
10.55 to 18.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 24.42
Confidence Interval (2-Sided) 95%
18.50 to 30.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 15.32
Confidence Interval (2-Sided) 95%
9.35 to 21.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.10
Confidence Interval (2-Sided) 95%
4.90 to 13.31
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])
Hide Description Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time Frame 6 to 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (8.8) 11.3  (9.2) 9.5  (8.9) 5.6  (8.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.26
Confidence Interval (2-Sided) 95%
6.59 to 11.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.84
Confidence Interval (2-Sided) 95%
-0.03 to 3.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.59
Confidence Interval (2-Sided) 95%
3.69 to 7.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.42
Confidence Interval (2-Sided) 95%
4.75 to 10.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.67
Confidence Interval (2-Sided) 95%
0.98 to 6.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.75
Confidence Interval (2-Sided) 95%
1.85 to 5.64
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose
Hide Description TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.
Time Frame 0 to 8 hours, 6 to 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
0 to 8 hours 5.3  (7.9) 18.4  (8.5) 15.4  (9.0) 11.4  (9.1)
6 to 8 hours 2.3  (3.8) 6.2  (4.1) 5.1  (4.0) 3.5  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 13.05
Confidence Interval (2-Sided) 95%
10.39 to 15.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.01
Confidence Interval (2-Sided) 95%
1.15 to 4.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.94
Confidence Interval (2-Sided) 95%
5.06 to 8.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 10.05
Confidence Interval (2-Sided) 95%
7.39 to 12.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.11
Confidence Interval (2-Sided) 95%
3.44 to 8.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.94
Confidence Interval (2-Sided) 95%
2.06 to 5.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.84
Confidence Interval (2-Sided) 95%
2.63 to 5.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.23 to 1.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.69
Confidence Interval (2-Sided) 95%
1.83 to 3.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.77
Confidence Interval (2-Sided) 95%
1.56 to 3.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
-0.07 to 2.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
0.76 to 2.47
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.
Time Frame 0 to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Median (95% Confidence Interval)
Unit of Measure: minutes
107.0
(86.0 to 173.0)
629.0
(570.0 to 720.0)
608.5
(545.0 to 671.0)
449.0
(399.0 to 547.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
5.Secondary Outcome
Title Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours
Hide Description Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.
Time Frame 6 hours, 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Measure Type: Number
Unit of Measure: percentage of participants
6 hour 67.9 10.5 21.7 38.8
8 hour 69.6 24.4 33.1 51.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -45.27
Confidence Interval (2-Sided) 95%
-58.96 to -31.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -8.88
Confidence Interval (2-Sided) 95%
-18.27 to 0.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -26.98
Confidence Interval (2-Sided) 95%
-36.91 to -17.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -36.26
Confidence Interval (2-Sided) 95%
-50.45 to -22.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -18.58
Confidence Interval (2-Sided) 95%
-32.64 to -4.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -18.17
Confidence Interval (2-Sided) 95%
-28.44 to -7.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -57.58
Confidence Interval (2-Sided) 95%
-70.44 to -44.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -11.28
Confidence Interval (2-Sided) 95%
-18.99 to -3.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -28.06
Confidence Interval (2-Sided) 95%
-36.77 to -19.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -46.01
Confidence Interval (2-Sided) 95%
-59.98 to -32.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -29.70
Confidence Interval (2-Sided) 95%
-43.65 to -15.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter CMH adjusted proportions
Estimated Value -16.94
Confidence Interval (2-Sided) 95%
-26.59 to -7.29
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to Onset of Meaningful Pain Relief
Hide Description Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Time Frame 0 to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, "number of participants analyzed" signifies those participants who had the event (meaningful pain relief).
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 16 147 139 118
Median (95% Confidence Interval)
Unit of Measure: minutes
NA [1] 
(NA to NA)
47.9
(41.6 to 57.4)
65.9
(57.2 to 81.6)
56.6
(50.5 to 84.6)
[1]
Data was not estimable as median time to onset of meaningful relief was greater than (>) 720 minutes for placebo group.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.631
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Time to Confirmed Onset of First Perceptible Relief
Hide Description Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.
Time Frame 0 to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, "number of participants analyzed" signifies those participants who had the event (first perceptiblre relief).
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 16 149 139 118
Median (95% Confidence Interval)
Unit of Measure: minutes
NA [1] 
(NA to NA)
21.3
(18.7 to 24.2)
24.6
(22.3 to 27.8)
24.2
(20.7 to 29.9)
[1]
Data was not estimable as median time to confirmed onset of first perceptible relief was >720 minutes for placebo group.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.887
Comments [Not Specified]
Method Gehan-Wilcoxon test
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Pain Relief Rating (PRR) Score
Hide Description Participants answered a question: "how much relief do you have from your starting pain?" on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief.
Time Frame 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.
Arm/Group Title Placebo Ibuprofen 250 mg + Acetaminophen 500 mg Ibuprofen 250 mg Acetaminophen 650 mg
Hide Arm/Group Description:
Participants received Placebo as a single oral dose caplet during the study of 12 hours.
Participants received a single oral dose of a fixed dose combination of ibuprofen 250 milligram (mg) and acetaminophen 500 mg caplets during the 12 hours study.
Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.
Overall Number of Participants Analyzed 56 172 175 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.25 hour 0.18  (0.39) 0.51  (0.65) 0.36  (0.61) 0.50  (0.70)
0.5 hour 0.30  (0.46) 1.29  (1.02) 1.11  (0.97) 1.20  (1.00)
1 hour 0.44  (0.63) 2.19  (1.22) 1.85  (1.18) 1.86  (1.14)
1.5 hour 0.48  (0.74) 2.47  (1.17) 2.08  (1.25) 1.90  (1.19)
2 hour 0.55  (0.96) 2.65  (1.21) 2.28  (1.33) 1.86  (1.25)
3 hour 0.70  (1.09) 2.75  (1.17) 2.35  (1.36) 1.66  (1.36)
4 hour 0.71  (1.16) 2.71  (1.23) 2.27  (1.39) 1.55  (1.39)
5 hour 0.73  (1.21) 2.64  (1.27) 2.18  (1.37) 1.50  (1.43)
6 hour 0.80  (1.31) 2.36  (1.37) 2.01  (1.42) 1.29  (1.43)
7 hour 0.77  (1.31) 2.04  (1.45) 1.68  (1.43) 1.14  (1.39)
8 hour 0.73  (1.24) 1.75  (1.47) 1.40  (1.41) 1.03  (1.37)
9 hour 0.73  (1.23) 1.41  (1.49) 1.31  (1.45) 0.95  (1.31)
10 hour 0.75  (1.24) 1.20  (1.47) 1.19  (1.43) 0.95  (1.37)
11 hour 0.78  (1.29) 1.06  (1.43) 1.03  (1.40) 0.88  (1.34)
12 hour 0.75  (1.25) 0.97  (1.35) 0.97  (1.40) 0.85  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.14 to 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.01 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.13 to 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.01 to 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.13 to 0.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.28 to -0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.70 to 1.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.03 to 0.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.12 to 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.52 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.61 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.29 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
1.40 to 2.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.10 to 0.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.08 to 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.07 to 1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.08 to 1.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.26 to 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
1.64 to 2.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.15 to 0.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.32 to 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.25 to 1.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.07 to 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.07 to 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.10
Confidence Interval (2-Sided) 95%
1.73 to 2.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.11 to 0.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.52 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.73
Confidence Interval (2-Sided) 95%
1.36 to 2.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.94 to 1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.15 to 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.06
Confidence Interval (2-Sided) 95%
1.67 to 2.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.13 to 0.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.82 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
1.27 to 2.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.58 to 1.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.42 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
1.60 to 2.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.16 to 0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.88 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
1.16 to 1.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.44 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.44 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
1.50 to 2.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.18 to 0.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.85 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.04 to 1.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.36 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.39 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.13 to 1.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.06 to 0.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.77 to 1.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.78 to 1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.06 to 0.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.42 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.84 to 1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.07 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.60 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.48 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-0.06 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.24 to 0.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.60 to 1.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.06 to 0.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.42 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.25 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.12 to 0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.07 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.26 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.19 to 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.16 to 0.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.15 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.21 to 0.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg, Acetaminophen 650 mg
Comments 9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.06 to 0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg + Acetaminophen 500 mg
Comments 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.02 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Ibuprofen 250 mg
Comments 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.28 to 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Ibuprofen 250 mg + Acetaminophen 500 mg, Acetaminophen 650 mg
Comments 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.05 to 0.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Placebo, Ibuprofen 250 mg
Comments 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.01 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Placebo, Acetaminophen 650 mg
Comments 10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.355
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.22 to 0.62
Estimation Comments [Not Specified]