Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Celebrex In Acute Gouty Arthritis Study

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: NCT00549549
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Gouty
Interventions Drug: Indomethacin
Drug: Celecoxib
Enrollment 402
Recruitment Details  
Pre-assignment Details A total of 443 participants were screened, of which 402 participants were assigned to treatment and 400 received treatment. One participant (indomethacin 50 mg) was not treated as they were no longer willing to participate in the study, and one participant (celecoxib 800/400 mg) was not treated due to due to insufficient drug quantity at site.
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description Participants received Celecoxib 50 mg twice daily for 8 days An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days. An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days. Indomethacin 50 mg three times daily for 8 days.
Period Title: Overall Study
Started 101 99 99 103
Treated 101 99 98 102
Completed 77 77 82 78
Not Completed 24 22 17 25
Reason Not Completed
Adverse Event             5             3             1             9
Lack of Efficacy             9             6             4             2
Lost to Follow-up             1             0             1             2
Withdrawal by Subject             0             4             1             0
Other             9             9             9             11
Randomized but not treated             0             0             1             1
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg Total
Hide Arm/Group Description Participants received Celecoxib 50 mg twice daily for 8 days An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days. An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days. Indomethacin 50 mg three times daily for 8 days. Total of all reporting groups
Overall Number of Baseline Participants 101 99 98 102 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 98 participants 102 participants 400 participants
Between 18 and 65 years 84 83 86 88 341
>=65 years 17 16 12 14 59
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 98 participants 102 participants 400 participants
Female
10
   9.9%
9
   9.1%
8
   8.2%
7
   6.9%
34
   8.5%
Male
91
  90.1%
90
  90.9%
90
  91.8%
95
  93.1%
366
  91.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 98 participants 102 participants 400 participants
White 53 64 54 55 226
Black 11 3 10 9 33
Asian 22 18 19 19 78
Other 15 14 15 19 63
1.Primary Outcome
Title Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Hide Description The Patient’s Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).
Time Frame Baseline and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 3.03  (0.67) 2.73  (0.62) 2.84  (0.69) 2.83  (0.76)
Change at Day 2 -1.14  (1.10) -1.23  (0.97) -1.51  (1.11) -1.62  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.74 to -0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.52 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.29 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.05 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.17 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Hide Description Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).
Time Frame Baseline, Day 5, Day 9, and Day 14/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 2.39  (0.72) 2.15  (0.75) 2.26  (0.65) 2.13  (0.70)
Change at Day 5 -1.44  (0.96) -1.39  (0.89) -1.58  (0.93) -1.52  (0.86)
Change at Day 9 -1.75  (0.98) -1.64  (0.93) -1.84  (0.92) -1.65  (0.87)
Change at Day 14/Early Termination -1.74  (1.09) -1.66  (1.01) -1.94  (0.88) -1.64  (0.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.29 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 5 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.42 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 5 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.04 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 5 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.04 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 5 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.16 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 9 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.26 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 9 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.40 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 9 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.11 to 0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 9 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.16 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 9 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.30 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.33 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.53 to -0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day /early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.05 to 0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.17 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.38 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Hide Description Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
Time Frame Baseline, Days 5, 9 and 14/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 2.16  (0.73) 2.08  (0.65) 2.09  (0.65) 2.01  (0.75)
Change at Day 5 -1.22  (1.09) -1.21  (1.05) -1.27  (0.97) -1.20  (0.96)
Change at Day 9 -1.47  (1.18) -1.54  (1.00) -1.62  (0.95) -1.58  (0.94)
Change at Day 14/Early Termination -1.55  (1.18) -1.63  (0.98) -1.78  (0.97) -1.58  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.29 to 0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 5 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.35 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 5 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.17 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 5 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.20 to 0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 5 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.26 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 9 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.36 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 9 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.44 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 9 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.01 to 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 9 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.14 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 9 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.22 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.38 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.52 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.08 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.22 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 14/early termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.36 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Redness Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination
Hide Description Redness was assessed by the physician as present or absent.
Time Frame Baseline, Day 5, Day 9 and Day 14/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Measure Type: Number
Unit of Measure: Participants
Baseline 84 88 79 85
Day 5 27 29 26 23
Day 9 12 15 13 11
Day 14/Early termination 15 15 7 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6402
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9739
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4581
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2962
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4951
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4957
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8364
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6892
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4110
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5981
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9317
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0831
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5747
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6204
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2556
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Warmth Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14
Hide Description Warmth was assessed by the physician as present or absent.
Time Frame Baseline, Day 5, Day 9 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Measure Type: Number
Unit of Measure: Participants
Baseline 89 91 91 88
Day 5 25 16 22 21
Day 9 13 8 9 11
DAY 14/E_TERM 19 7 11 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1444
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7532
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4722
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3878
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6717
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3098
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4356
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5703
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4986
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7855
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0169
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1353
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3690
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0787
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 14/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5687
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Patient’s Assessment of Pain Intensity
Hide Description The Patient’s assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Time Frame Baseline, Day 2 to Day 13
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 3.03  (0.67) 2.73  (0.62) 2.84  (0.69) 2.83  (0.76)
Change at Day 1 -0.65  (0.87) -0.85  (0.86) -1.06  (1.08) -1.10  (0.92)
Change at Day 2 -1.14  (1.10) -1.23  (0.97) -1.51  (1.11) -1.62  (0.97)
Change at Day 3 -1.32  (1.15) -1.42  (0.98) -1.78  (1.09) -1.84  (0.97)
Change at Day 4 -1.52  (1.16) -1.60  (0.98) -1.96  (1.08) -2.02  (1.00)
Change at Day 5 -1.52  (1.16) -1.67  (1.04) -2.05  (1.10) -2.04  (1.03)
Change at Day 6 -1.68  (1.15) -1.84  (1.05) -2.12  (1.06) -2.11  (1.01)
Change at Day 7 -1.79  (1.23) -1.90  (1.16) -2.29  (1.05) -2.15  (1.02)
Change at Day 8 -1.88  (1.26) -1.95  (1.12) -2.30  (0.98) -2.16  (1.04)
Change at Day 9 -1.86  (1.27) -1.96  (1.12) -2.24  (1.04) -2.19  (1.08)
Change at Day 10 -1.90  (1.27) -1.99  (1.13) -2.23  (1.13) -2.17  (1.01)
Change at Day 11 -1.89  (1.31) -1.94  (1.13) -2.22  (1.15) -2.15  (1.02)
Change at Day 12 -1.93  (1.32) -1.95  (1.18) -2.27  (1.09) -2.07  (1.07)
Change at Day 13/Early termination -1.91  (1.34) -1.95  (1.18) -2.27  (1.08) -1.98  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.60 to -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 1 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.75 to -0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 1 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.29 to 0.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 1 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.06 to 0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 1 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.21 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 2 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.52 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 2 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.74 to -0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 2 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.29 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 2 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.05 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 2 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.17 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 3 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.53 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 3 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.83 to -0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 3 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.32 to 0.88
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 3 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.08 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 3 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.22 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 4 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.56 to -0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 4 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.84 to -0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 4 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.35 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 4 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.07 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 4 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.21 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.64 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.94 to -0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.37 to 0.93
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.02 to 0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 5 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.29 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 6 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.65 to -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 6 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.84 to -0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 6 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.29 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 6 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.08 to 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 6 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.28 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 7 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.61 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 7 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-0.92 to -0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 7 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.21 to 0.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 7 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.11 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 7 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.42 to 0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 8 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.57 to -0.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 8 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.84 to -0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 8 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.14 to 0.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 8 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.15 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 8 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.42 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.61 to -0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-0.82 to -0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.18 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.13 to 0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 9 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.35 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 10 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.59 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 10 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.76 to -0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 10 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.10 to 0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 10 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.18 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 10 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.36 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 11 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.56 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 11 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.77 to -0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 11 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.10 to 0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 11 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.16 to 0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 11 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.37 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 12 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.53 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 12 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.77 to -0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 12 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-0.04 to 0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 12 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.25 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 12 analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.50 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 400/200 mg
Comments Day 13/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.56 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 62 Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Celecoxib 800/400 mg
Comments Day 13/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-0.81 to -0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Celecoxib 50 mg, Indomethacin 50 mg
Comments Day 13/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.10 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 64 Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Celecoxib 400/200 mg, Indomethacin 50 mg
Comments Day 13/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.35 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Celecoxib 800/400 mg, Indomethacin 50 mg
Comments Day 13/Early Termination analyses
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.60 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Patient’s Assessment of Pain Intensity on Day 1
Hide Description The patient’s assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).
Time Frame Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF
Arm/Group Title Celecoxib 50 mg Celecoxib 400/200 mg Celecoxib 800/400 mg Indomethacin 50 mg
Hide Arm/Group Description:
Participants received Celecoxib 50 mg twice daily for 8 days
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
Indomethacin 50 mg three times daily for 8 days.
Overall Number of Participants Analyzed 100 99 96 102