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Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

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ClinicalTrials.gov Identifier: NCT00446797
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : June 10, 2009
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankle Sprain
Interventions Drug: Non-selective NSAIDS
Drug: Celecoxib
Enrollment 278
Recruitment Details Locations used were emergency rooms at orthopedic hospitals, general hospitals or private doctor’s offices
Pre-assignment Details Subjects sustained ankle sprain with a pain rating of greater than or equal to 45mm on a visual analog scale on full weight bearing, no more than 48 hours prior to the first dose of study medication
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses. All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Period Title: Overall Study
Started 141 137
Completed 133 125
Not Completed 8 12
Reason Not Completed
Lack of Efficacy             0             2
Lost to Follow-up             5             3
Withdrawal by Subject             2             2
Protocol Violation             1             3
subject entered at another site             0             1
did not meet entrance criteria             0             1
Arm/Group Title Celecoxib nsNSAIDs Total
Hide Arm/Group Description All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses. All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days. Total of all reporting groups
Overall Number of Baseline Participants 141 137 278
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 141 participants 137 participants 278 participants
30.6
(18 to 66)
30.4
(18 to 74)
30.5
(18 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 137 participants 278 participants
Female
56
  39.7%
55
  40.1%
111.0
Male
85
  60.3%
82
  59.9%
167.0
1.Primary Outcome
Title Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
Hide Description Assessment of ankle pain by VAS: 100 mm horizontal line with left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline
Time Frame Baseline and day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 131 126
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-44.88  (19.75) -40.76  (18.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Least squares mean
Type of Statistical Test Non-Inferiority or Equivalence
Comments To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than –10 mm.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Terms for treatment, country (fixed), and the baseline pain VAS score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.39
Confidence Interval 95%
-0.76 to 7.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.11
Estimation Comments Direction: nsNSAIDs minus celecoxib
2.Secondary Outcome
Title Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Hide Description Assessment of ankle pain by VAS: 100 mm horizontal line, left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline
Time Frame Baseline and days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 -29.25  (18.99) -25.98  (18.21)
Day 3 -44.87  (19.51) -40.75  (18.74)
Day 7 -61.17  (18.43) -57.89  (18.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Terms for treatment, country (fixed) and the baseline pain VAS score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.10
Confidence Interval 95%
-0.89 to 7.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.02
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Terms for treatment, country (fixed) and the baseline pain VAS score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.46
Confidence Interval 95%
-0.55 to 7.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.04
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Terms for treatment, country (fixed) and the baseline pain VAS score
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.76
Confidence Interval 95%
-0.91 to 6.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.86
Estimation Comments Direction: nsNSAIDs minus celecoxib
3.Secondary Outcome
Title Number of Subjects Responding (Improving) - MITT Population
Hide Description The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale
Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: participants
Day 2 - response (N=134, 133) 91 79
Day 2 - no response 43 54
Day 3 - response (N=135, 131) 124 116
Day 3 - no response 11 15
Day 7 - response (N=133, 125) 129 120
Day 7 - no response 4 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1591
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Regression, Logistic
Comments Terms for treatment and the baseline pain VAS score
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3995
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Regression, Logistic
Comments Terms for treatment and the baseline pain VAS score
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6805
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Regression, Logistic
Comments Terms for treatment and the baseline pain VAS score
4.Secondary Outcome
Title Subject's Global Assessment of Ankle Injury
Hide Description Subject response to question: “Considering all the ways your ankle injury affects you, how are you doing today?” Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).
Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: participants
Day 2 - Very good (no symptoms) (N=135, 133) 1 1
Day 2 - Good (mild symptoms) 40 31
Day 2 - Fair (moderate symptoms) 76 80
Day 2 - Poor (severe symptoms) 17 19
Day 2- Very poor (very severe symptoms) 1 2
Day 3 - Very good (no symptoms) (N=135, 131) 8 6
Day 3 - Good (mild symptoms) 68 55
Day 3 - Fair (moderate symptoms) 54 63
Day 3 - Poor (severe symptoms) 5 7
Day 3 - Very poor (very severe symptoms) 0 0
Day 7 - Very good (no symptoms) (N=133, 125) 53 37
Day 7 - Good (mild symptoms) 61 63
Day 7 - Fair (moderate symptoms) 17 21
Day 7 - Poor (severe symptoms) 2 4
Day 7 - Very poor (very severe symptoms) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2411
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1163
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0440
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
5.Secondary Outcome
Title Physician Global Assessment of Ankle Injury
Hide Description Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)
Time Frame Days 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: participants
Day 3 - very mild (N=134, 131) 20 12
Day 3 - mild 71 79
Day 3 - moderate 40 38
Day 3 - severe 2 2
Day 3 - very severe 1 0
Day 7 - very mild (N=132, 125) 87 70
Day 7 - mild 38 47
Day 7 - moderate 7 7
Day 7 - severe 0 1
Day 7 - very severe 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7223
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments

Controlled for country

Test of row mean score differences based on modified ridits (standardizing the mid-rank)

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0541
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments

Controlled for country

Test of row mean score differences based on modified ridits (standardizing the mid-rank)

6.Secondary Outcome
Title Pain Relief - MITT Population
Hide Description Subject's response to the statement "My relief from starting pain is". Scale from 0 = None to 4 = Complete.
Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: participants
Day 2 - None (N=135, 132) 8 5
Day 2 - A little 25 33
Day 2 - Some 49 52
Day 2 - A lot 52 42
Day 2 -Complete 1 0
Day 3 - None (N=135, 131) 0 1
Day 3 - A little 15 21
Day 3 - Some 33 46
Day 3 - A lot 84 60
Day 3 -Complete 3 3
Day 7 - None (N=133, 125) 1 1
Day 7 - A little 6 3
Day 7 - Some 7 15
Day 7 - A lot 77 80
Day 7 -Complete 42 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2900
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments

Controlled for country

Test of row mean score differences based on modified ridits (standardizing the mid-rank)

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0157
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments

Controlled for country

Test of row mean score differences based on modified ridits (standardizing the mid-rank)

Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1206
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments

Controlled for country

Test of row mean score differences based on modified ridits (standardizing the mid-rank)

7.Secondary Outcome
Title Subject Assessment of Normal Function / Activity
Hide Description Subject response to question: “How does your ankle injury affect your walking and normal activity?” Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can’t resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)
Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Measure Type: Number
Unit of Measure: participants
Day 2 - normal no pain (N =135, 133) 5 2
Day 2 - normal with pain 40 30
Day 2 - mildly restricted 59 55
Day 2 - moderately restricted 19 39
Day 2 - severely restricted 12 7
Day 3 - normal no pain (N = 135, 131) 18 13
Day 3 - normal with pain 52 46
Day 3 - mildly restricted 49 57
Day 3 - moderately restricted 14 11
Day 3 - severely restricted 2 4
Day 7 - normal no pain (N = 133, 125) 62 43
Day 7 - normal with pain 55 68
Day 7 - mildly restricted 11 8
Day 7 - moderately restricted 4 3
Day 7 - severely restricted 1 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0846
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3041
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1216
Comments Threshold for statistical significance: p value is less than or equal to 0.05
Method Cochran-Mantel-Haenszel
Comments Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)
8.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine

Time Frame Days 1, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 5.71  (2.04) 5.90  (2.06)
Day 3 (N = 135, 131) 3.81  (1.84) 4.44  (1.91)
Day 7 (N = 133, 125) 2.08  (1.93) 2.38  (1.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments Overall p-value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval 95%
-0.33 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.61
Confidence Interval 95%
0.18 to 1.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval 95%
-0.08 to 0.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments Direction: nsNSAIDs minus celecoxib
9.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 133, 133) 3.25  (1.83) 3.36  (1.88)
Day 3 (N = 135, 131) 2.07  (1.68) 2.40  (1.64)
Day 7 (N = 133, 125) 0.83  (1.26) 1.16  (1.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval 95%
-0.32 to 0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval 95%
-0.07 to 0.63
Parameter Dispersion
Type: Standard Deviation
Value: 0.18
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval 95%
0.03 to 0.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments Direction: nsNSAIDs minus celecoxib
10.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 4.34  (1.79) 4.41  (1.90)
Day 3 (N = 135, 131) 2.90  (1.70) 3.26  (1.63)
Day 7 (N = 133, 125) 1.41  (1.56) 1.74  (1.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval 95%
-0.36 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.36
Confidence Interval 95%
-0.01 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval 95%
-0.01 to 0.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments Direction: nsNSAIDs minus celecoxib
11.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 3.64  (2.05) 4.23  (2.26)
Day 3 (N =135, 131) 2.58  (1.81) 2.92  (1.78)
Day 7 (N = 133, 125) 1.14  (1.56) 1.43  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval 95%
0.11 to 1.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval 95%
-0.05 to 0.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval 95%
-0.01 to 0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments Direction: nsNSAIDs minus celecoxib
12.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 4.24  (1.66) 4.48  (1.84)
Day 3 (N = 135, 131) 2.84  (1.61) 3.26  (1.57)
Day 7 (N = 133, 125) 1.37  (1.47) 1.68  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.21
Confidence Interval 95%
-0.17 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval 95%
0.05 to 0.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval 95%
0.01 to 0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments Direction: nsNSAIDs minus celecoxib
13.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5A
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 5.40  (2.52) 5.37  (2.62)
Day 3 (N = 135, 131) 3.65  (2.64) 4.07  (2.60)
Day 7 (N = 133, 125) 1.78  (2.13) 1.90  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval 95%
-0.64 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval 95%
-0.19 to 1.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval 95%
-0.30 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
14.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5B
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 3.72  (2.95) 3.64  (2.87)
Day 3 (N = 135, 131) 2.43  (2.41) 2.38  (2.60)
Day 7 (N = 133, 125) 1.17  (2.06) 1.26  (2.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval 95%
-0.75 to 0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval 95%
-0.62 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval 95%
-0.33 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
15.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5C
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 5.10  (2.76) 5.11  (2.74)
Day 3 (N = 135, 131) 3.58  (2.62) 3.69  (2.67)
Day 7 (N = 133, 125) 1.65  (2.19) 1.62  (1.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.59 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval 95%
-0.50 to 0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
-0.44 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
16.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5D
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 5.29  (2.95) 5.39  (2.76)
Day 3 (N = 135, 131) 4.04  (2.92) 4.04  (2.88)
Day 7 (N = 133, 125) 1.84  (2.42) 1.87  (2.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval 95%
-0.53 to 0.75
Parameter Dispersion
Type: Standard Deviation
Value: 0.32
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.972
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.69 to 0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval 95%
-0.47 to 0.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments Direction: nsNSAIDs minus celecoxib
17.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5E
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 2.70  (2.78) 2.67  (2.68)
Day 3 (N = 135, 131) 1.81  (2.26) 1.69  (2.26)
Day 7 (N = 133, 125) 0.80  (1.70) 0.78  (1.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval 95%
-0.63 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval 95%
-0.62 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.952
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval 95%
-0.36 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments Direction: nsNSAIDs minus celecoxib
18.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5F
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 2.97  (2.88) 2.87  (2.64)
Day 3 (N = 135, 131) 1.90  (2.40) 1.86  (2.28)
Day 7 (N = 133, 125) 0.68  (1.77) 0.82  (1.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval 95%
-0.65 to 0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.31
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.57 to 0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.542
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval 95%
-0.30 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments Direction: nsNSAIDs minus celecoxib
19.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5G
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
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Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
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All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 3.33  (3.17) 2.99  (2.81)
Day 3 (N = 135, 131) 2.13  (2.69) 2.06  (2.48)
Day 7 (N = 133, 125) 1.07  (1.98) 1.10  (1.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval 95%
-0.92 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval 95%
-0.53 to 0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval 95%
-0.37 to 0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments Direction: nsNSAIDs minus celecoxib
20.Secondary Outcome
Title Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Index
Hide Description

m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.

The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes

Time Frame Days 2, 3 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
Overall Number of Participants Analyzed 135 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Day 2 (N = 134, 133) 4.07  (2.34) 4.01  (2.12)
Day 3 (N = 135, 131) 2.79  (2.15) 2.83  (2.07)
Day 7 (N = 133, 125) 1.28  (1.81) 1.33  (1.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 2 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.887
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval 95%
-0.54 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 3 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval 95%
-0.43 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments Direction: nsNSAIDs minus celecoxib
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, nsNSAIDs
Comments Day 7 Least squares mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments Overall p value
Method ANCOVA
Comments Terms for treatment and country
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval 95%
-0.30 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments Direction: nsNSAIDs minus celecoxib
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses. All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
All-Cause Mortality
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   0   2 
Infections and infestations     
Dengue fever  1  0/141 (0.00%)  1/137 (0.73%) 
Injury, poisoning and procedural complications     
Tendon rupture  1  0/141 (0.00%)  1/137 (0.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   13   17 
Gastrointestinal disorders     
Abdominal pain upper  1  0/141 (0.00%)  2/137 (1.46%) 
Diarrhoea  1  1/141 (0.71%)  2/137 (1.46%) 
Dyspepsia  1  1/141 (0.71%)  2/137 (1.46%) 
Gastritis  1  2/141 (1.42%)  5/137 (3.65%) 
Hyperchlorhydria  1  1/141 (0.71%)  3/137 (2.19%) 
Nausea  1  1/141 (0.71%)  2/137 (1.46%) 
Nervous system disorders     
Headache  1  3/141 (2.13%)  0/137 (0.00%) 
Somnolence  1  5/141 (3.55%)  2/137 (1.46%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00446797     History of Changes
Other Study ID Numbers: A3191332
First Submitted: March 9, 2007
First Posted: March 13, 2007
Results First Submitted: April 21, 2009
Results First Posted: June 10, 2009
Last Update Posted: June 25, 2009