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Trial record 94 of 299 for:    "Ankylosing spondylitis"

Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00762463
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : August 23, 2011
Last Update Posted : August 23, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Celecoxib
Drug: Diclofenac SR
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description Celecoxib 200 milligram (mg) capsule once daily Diclofenac sustained release (SR) 75 mg tablet once daily Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Period Title: Double-blind Phase (Baseline to Week 6)
Started 120 120 0 0
Completed 113 110 0 0
Not Completed 7 10 0 0
Reason Not Completed
Insufficient clinical response             2             2             0             0
No longer willing to participate             3             4             0             0
Adverse Event             2             4             0             0
Period Title: Enrollment in Extension Phase (Week 6)
Started 113 110 0 0
Completed 109 109 0 0
Not Completed 4 1 0 0
Reason Not Completed
Did not sign 2nd informed consent form             4             1             0             0
Period Title: Extension Phase (Week 6 to Week 12)
Started 55 55 54 54
Completed 52 54 50 52
Not Completed 3 1 4 2
Reason Not Completed
Lost to Follow-up             1             0             1             0
Insufficient clinical response             1             1             0             1
No longer willing to participate             1             0             3             0
Not specified             0             0             0             1
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Total
Hide Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily Total of all reporting groups
Overall Number of Baseline Participants 120 120 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
18 - 44 years 109 109 218
45 - 64 years 11 11 22
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
Female
15
  12.5%
19
  15.8%
34
  14.2%
Male
105
  87.5%
101
  84.2%
206
  85.8%
1.Primary Outcome
Title Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
Hide Description 100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 111 108
Least Squares Mean (Standard Error)
Unit of Measure: mm
-23.8  (1.98) -27.1  (2.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments

Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was <10 mm.

For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided).

Type of Statistical Test Non-Inferiority or Equivalence
Comments LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was <10 mm.
Statistical Test of Hypothesis P-Value 0.0085
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient’s Assessment of Global Pain Intensity score.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-2.2 to 8.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.79
Estimation Comments [Not Specified]
2.Primary Outcome
Title Participant's Assessment of Global Pain Intensity at Baseline
Hide Description 100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
PP
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 111 108
Mean (Standard Deviation)
Unit of Measure: mm
62.9  (12.68) 63.6  (13.38)
3.Secondary Outcome
Title Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
Hide Description 100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: mm
Week 2 (n=116, 115) -18.6  (1.78) -17.9  (1.79)
Week 4 (n=117, 115) -20.7  (1.86) -23.3  (1.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7849
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-5.6 to 4.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3223
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-2.6 to 7.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.62
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
Hide Description 100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=55, 55, 54, 54) 63.4  (13.58) 61.1  (13.08) 63.4  (12.05) 65.6  (13.26)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -28.4  (21.39) -30.9  (24.24) -20.8  (21.86) -28.1  (25.96)
5.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6
Hide Description 5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=116, 115) -0.4  (0.06) -0.4  (0.06)
Week 4 (n=117, 115) -0.3  (0.06) -0.4  (0.06)
Week 6 (n=117, 115) -0.3  (0.06) -0.4  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8938
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.15 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0426
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.01 to 0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1502
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.05 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
Hide Description 5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=55, 55, 54, 54) 3.1  (0.83) 3.0  (0.64) 3.2  (0.66) 3.2  (0.70)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -0.6  (0.99) -0.6  (0.78) -0.4  (0.71) -0.6  (0.96)
7.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6
Hide Description 5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=116, 115) -0.4  (0.05) -0.4  (0.05)
Week 4 (n=117, 115) -0.4  (0.05) -0.5  (0.05)
Week 6 (n=117, 115) -0.5  (0.06) -0.5  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5945
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3427
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6522
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
Hide Description 5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=55, 55, 54, 54) 3.2  (0.57) 3.0  (0.45) 3.2  (0.43) 3.3  (0.50)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -0.7  (0.60) -0.5  (0.64) -0.5  (0.51) -0.7  (0.75)
9.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6
Hide Description Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: mm
Week 2 (n=116, 115) -0.3  (0.13) -0.3  (0.13)
Week 4 (n=117, 115) -0.4  (0.14) -0.6  (0.14)
Week 6 (n=117, 115) -0.5  (0.15) -0.8  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9358
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5916
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1790
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.1 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in BASFI at Week 12
Hide Description BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=55, 55, 54, 54) 3.4  (1.98) 3.5  (2.13) 3.5  (1.83) 3.5  (2.25)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -0.9  (1.78) -1.0  (1.64) -0.6  (1.97) -1.0  (2.30)
11.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6
Hide Description Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: mm
Week 2 (n=116, 115) -0.8  (0.14) -0.9  (0.14)
Week 4 (n=117, 115) -0.9  (0.15) -1.1  (0.15)
Week 6 (n=117, 115) -1.1  (0.16) -1.4  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6335
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2729
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.2 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1559
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.1 to 0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in BASDAI at Week 12
Hide Description BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=55, 55, 54, 54) 4.71  (1.79) 4.9  (1.80) 4.7  (1.48) 4.9  (1.88)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -1.7  (1.86) -2.1  (1.94) -0.6  (1.87) -1.4  (2.14)
13.Secondary Outcome
Title Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20
Hide Description Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).
Time Frame Weeks 2, 4, 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 116 114 55 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=115, 114) 23.5 25.4 0 0
Week 4 (n=116, 114) 26.7 31.6 0 0
Week 6 (n=54, 54, 54, 54) 40.7 42.6 22.2 29.6
Week 12 (n=51, 53, 46, 51) 49.0 47.2 32.6 37.3
14.Secondary Outcome
Title Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
Hide Description 100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 117 115
Least Squares Mean (Standard Error)
Unit of Measure: mm
Week 2 (n=116, 115) -12.0  (1.90) -16.3  (1.91)
Week 4 (n=117, 115) -14.5  (1.94) -17.1  (1.96)
Week 6 (n=117, 115) -15.4  (1.95) -19.4  (1.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1111
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-1.0 to 9.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3574
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-2.9 to 7.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.74
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1464
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-1.4 to 9.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.76
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Nocturnal Pain at Week 12
Hide Description 100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=55, 55, 54, 54) 52.2  (20.45) 55.1  (19.24) 54.5  (20.14) 61.5  (19.17)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -19.4  (22.54) -27.5  (25.62) -12.5  (20.31) -22.6  (30.36)
16.Secondary Outcome
Title Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6
Hide Description Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 118 115
Least Squares Mean (Standard Error)
Unit of Measure: cm
Week 2 (n=117, 115) -1.6  (0.62) -1.6  (0.62)
Week 4 (n=118, 115) -1.9  (0.69) -2.2  (0.71)
Week 6 (n=118, 115) -2.8  (0.67) -3.1  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9641
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.7 to 1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7749
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.6 to 2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7529
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.6 to 2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.95
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Fingertips to Floor Distance at Week 12
Hide Description Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n=55, 55, 54, 54) 14.8  (12.89) 17.6  (15.23) 22.9  (19.49) 14.6  (14.48)
Change from Baseline at Week 12 (n=52, 54, 46, 51) -3.0  (9.38) -3.7  (6.82) -3.1  (8.18) -1.3  (7.75)
18.Secondary Outcome
Title Change From Baseline in Chest Expansion at Weeks 2, 4, and 6
Hide Description Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.
Time Frame Baseline, Weeks 2, 4, 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. N = total evaluable participants. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 118 115
Least Squares Mean (Standard Error)
Unit of Measure: cm
Week 2 (n=117, 115) 0.2  (0.08) 0.3  (0.08)
Week 4 (n=118, 115) 0.6  (0.09) 0.4  (0.09)
Week 6 (n=118, 115) 0.7  (0.10) 0.6  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8780
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.2
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 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2202
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.4
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 200 mg, Diclofenac SR 75 mg
Comments Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5340
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Chest Expansion at Week 12
Hide Description Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 55 55 54 54
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n=55, 55, 54, 54) 3.9  (1.93) 3.8  (1.63) 3.6  (1.82) 3.8  (1.62)
Change from Baseline at Week 12 (n=52, 54, 46, 51) 0.8  (1.26) 0.8  (1.39) 0.8  (1.29) 0.8  (1.02)
20.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6
Hide Description Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 108 110
Least Squares Mean (Standard Error)
Unit of Measure: mm/h
-2.5  (1.30) -1.8  (1.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7003
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.3 to 2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.81
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in ESR at Week 12
Hide Description ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 54 54 52 54
Mean (Standard Deviation)
Unit of Measure: mm/h
Baseline (n=54, 54, 52, 54) 20.9  (14.60) 20.8  (18.98) 22.8  (21.99) 23.6  (19.64)
Change from Baseline at Week 12 (n=45, 44, 41, 43) -3.5  (13.96) -1.3  (11.14) -6.3  (13.46) -0.7  (19.47)
22.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 6
Hide Description C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.
Time Frame Baseline, 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 109 110
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-4.16  (1.587) -2.72  (1.600)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Diclofenac SR 75 mg
Comments The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5183
Comments [Not Specified]
Method ANCOVA
Comments Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.44
Confidence Interval (2-Sided) 95%
-5.82 to 2.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.221
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in CRP at Week 12
Hide Description CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = evaluable participants at that time point.
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
Overall Number of Participants Analyzed 53 55 53 54
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline (n=53, 55, 53, 54) 18.53  (28.749) 15.84  (20.464) 18.80  (25.774) 21.01  (21.360)
Change from Baseline at Week 12 (n=47, 49, 42, 47) -4.58  (9.682) -2.99  (13.242) -4.77  (24.656) -2.13  (20.879)
24.Secondary Outcome
Title Percentage of Participants With Concomitant Use of Paracetamol
Hide Description Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 120 120
Measure Type: Number
Unit of Measure: percentage of participants
2.5 0.0
25.Secondary Outcome
Title Percentage of Days With Concomitant Administration of Paracetamol
Hide Description Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 120 120
Mean (Standard Deviation)
Unit of Measure: percentage of days
0.1  (0.08) 0.0  (0.00)
26.Secondary Outcome
Title Paracetamol Tablets Taken Per Day by Participant
Hide Description Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Hide Arm/Group Description:
Celecoxib 200 mg capsule once daily
Diclofenac SR 75 mg tablet once daily
Overall Number of Participants Analyzed 120 120
Mean (Standard Deviation)
Unit of Measure: tablets per day
0.2  (0.16) 0.0  (0.00)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 200 mg Diclofenac SR 75 mg, Then Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Hide Arm/Group Description Celecoxib 200 mg capsule once daily from baseline to Week 6 Diclofenac SR 75 mg tablet once daily from baseline to Week 6 Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12 Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12 Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12 Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
All-Cause Mortality
Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 200 mg Diclofenac SR 75 mg, Then Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 200 mg Diclofenac SR 75 mg, Then Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/120 (0.00%)   0/54 (0.00%)   0/55 (0.00%)   0/53 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib 200 mg Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 200 mg Diclofenac SR 75 mg, Then Diclofenac SR 75 mg Celecoxib 200 mg, Then Celecoxib 400 mg Diclofenac SR 75 mg, Then Celecoxib 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/120 (9.17%)   9/120 (7.50%)   0/54 (0.00%)   6/55 (10.91%)   5/53 (9.43%)   6/54 (11.11%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/53 (0.00%)  0/54 (0.00%) 
Leukopenia * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Cardiac disorders             
Wolff-Parkinson-White Syndrome * 1  0/120 (0.00%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Eye disorders             
Uveitis * 1  0/120 (0.00%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Gastrointestinal disorders             
Abdominal discomfort * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Abdominal pain * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  1/54 (1.85%) 
Abdominal pain upper * 1  1/120 (0.83%)  2/120 (1.67%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Dyspepsia * 1  0/120 (0.00%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Epigastric discomfort * 1  0/120 (0.00%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Mouth ulceration * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Hepatobiliary disorders             
Hepatic function abnormal * 1  0/120 (0.00%)  2/120 (1.67%)  0/54 (0.00%)  1/55 (1.82%)  0/53 (0.00%)  1/54 (1.85%) 
Infections and infestations             
Bronchitis * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/53 (1.89%)  0/54 (0.00%) 
Gastroenteritis * 1  0/120 (0.00%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Upper respiratory tract infection * 1  4/120 (3.33%)  1/120 (0.83%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  2/54 (3.70%) 
Investigations             
Alanine aminotransferase increased * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  2/55 (3.64%)  1/53 (1.89%)  2/54 (3.70%) 
Aspartate aminotransferase increased * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/53 (0.00%)  0/54 (0.00%) 
Red blood cell urine positive * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  0/53 (0.00%)  0/54 (0.00%) 
Transaminases increased * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  1/55 (1.82%)  1/53 (1.89%)  0/54 (0.00%) 
Weight decreased * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/53 (1.89%)  0/54 (0.00%) 
White blood cell count decreased * 1  0/120 (0.00%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  1/53 (1.89%)  0/54 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Nervous system disorders             
VIIth nerve paralysis * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
Skin and subcutaneous tissue disorders             
Rash generalised * 1  1/120 (0.83%)  0/120 (0.00%)  0/54 (0.00%)  0/55 (0.00%)  0/53 (0.00%)  0/54 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
The protocol does not specify time points for secondary endpoints; these are described in the statistical analysis plan.
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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00762463     History of Changes
Other Study ID Numbers: A3191348
First Submitted: September 29, 2008
First Posted: September 30, 2008
Results First Submitted: June 17, 2011
Results First Posted: August 23, 2011
Last Update Posted: August 23, 2011