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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00762463
Collaborator
(none)
240
5
2
13
48
3.7

Study Details

Study Description

Brief Summary

This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Celecoxib 200 mg QD

Drug: Celecoxib
capsule, 200 mg QD, 6-12 weeks

Active Comparator: Diclofenac SR 75 mg QD

Drug: Diclofenac SR
tablet, 75 mg QD,6-12 weeks

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6 [Baseline, Week 6]

    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.

  2. Participant's Assessment of Global Pain Intensity at Baseline [Baseline]

    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.

Secondary Outcome Measures

  1. Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4 [Baseline, Weeks 2, 4]

    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.

  2. Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12 [Baseline, Week 12]

    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.

  3. Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  4. Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12 [Baseline, Week 12]

    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.

  5. Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  6. Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 [Baseline, Week 12]

    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.

  7. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  8. Change From Baseline in BASFI at Week 12 [Baseline, Week 12]

    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.

  9. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  10. Change From Baseline in BASDAI at Week 12 [Baseline, Week 12]

    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.

  11. Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20 [Weeks 2, 4, 6, 12]

    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).

  12. Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  13. Change From Baseline in Nocturnal Pain at Week 12 [Baseline, Week 12]

    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.

  14. Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  15. Change From Baseline in Fingertips to Floor Distance at Week 12 [Baseline, Week 12]

    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.

  16. Change From Baseline in Chest Expansion at Weeks 2, 4, and 6 [Baseline, Weeks 2, 4, 6]

    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.

  17. Change From Baseline in Chest Expansion at Week 12 [Baseline, Week 12]

    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.

  18. Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6 [Baseline, Week 6]

    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.

  19. Change From Baseline in ESR at Week 12 [Baseline, Week 12]

    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.

  20. Change From Baseline in C-Reactive Protein (CRP) at Week 6 [Baseline, 6 Weeks]

    C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.

  21. Change From Baseline in CRP at Week 12 [Baseline, Week 12]

    CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.

  22. Percentage of Participants With Concomitant Use of Paracetamol [Week 6]

    Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6

  23. Percentage of Days With Concomitant Administration of Paracetamol [Week 6]

    Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.

  24. Paracetamol Tablets Taken Per Day by Participant [Week 6]

    Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis

  • With axial involvement

  • Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)

  • Need for daily treatment with NSAIDs during the previous 30 days before study entry

Exclusion Criteria:
  • Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)

  • Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)

  • Known vertebral compression

  • Need for a corset during the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Guangzhou Guangdong China 510630
2 Pfizer Investigational Site Xi'an Shanxi China 710032
3 Pfizer Investigational Site Chengdu Sichuan China 610041
4 Pfizer Investigational Site Beijing China 100020
5 Pfizer Investigational Site Beijing China 100853

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00762463
Other Study ID Numbers:
  • A3191348
First Posted:
Sep 30, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
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
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
Period Title: Double-blind Phase (Baseline to Week 6)
STARTED 113 110 0 0
COMPLETED 109 109 0 0
NOT COMPLETED 4 1 0 0
Period Title: Double-blind Phase (Baseline to Week 6)
STARTED 55 55 54 54
COMPLETED 52 54 50 52
NOT COMPLETED 3 1 4 2

Baseline Characteristics

Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg Total
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily Total of all reporting groups
Overall Participants 120 120 240
Age, Customized (participants) [Number]
18 - 44 years
109
90.8%
109
90.8%
218
90.8%
45 - 64 years
11
9.2%
11
9.2%
22
9.2%
Sex: Female, Male (Count of Participants)
Female
15
12.5%
19
15.8%
34
14.2%
Male
105
87.5%
101
84.2%
206
85.8%

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 111 108
Least Squares Mean (Standard Error) [mm]
-23.8
(1.98)
-27.1
(2.02)
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 (legacy)
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
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
2. Primary Outcome
Title Participant's Assessment of Global Pain Intensity at Baseline
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

Outcome Measure Data

Analysis Population Description
PP
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 111 108
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.7849
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.3223
Comments
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
4. Secondary Outcome
Title Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.8938
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.0426
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1502
Comments
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
6. Secondary Outcome
Title Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.5945
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.3427
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.6522
Comments
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
8. Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.9358
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.5916
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1790
Comments
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
10. Secondary Outcome
Title Change From Baseline in BASFI at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.6335
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.2729
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1559
Comments
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
12. Secondary Outcome
Title Change From Baseline in BASDAI at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
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
Measure Participants 116 114 55 55
Week 2 (n=115, 114)
23.5
19.6%
25.4
21.2%
0
0%
0
NaN
Week 4 (n=116, 114)
26.7
22.3%
31.6
26.3%
0
0%
0
NaN
Week 6 (n=54, 54, 54, 54)
40.7
33.9%
42.6
35.5%
22.2
9.3%
29.6
NaN
Week 12 (n=51, 53, 46, 51)
49.0
40.8%
47.2
39.3%
32.6
13.6%
37.3
NaN
14. Secondary Outcome
Title Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 117 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1111
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.3574
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.1464
Comments
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
15. Secondary Outcome
Title Change From Baseline in Nocturnal Pain at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 118 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.9641
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.7749
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.7529
Comments
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
17. Secondary Outcome
Title Change From Baseline in Fingertips to Floor Distance at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

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
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 118 115
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)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.8780
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.2202
Comments
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
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.5340
Comments
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
19. Secondary Outcome
Title Change From Baseline in Chest Expansion at Week 12
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

Outcome Measure Data

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
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
Measure Participants 55 55 54 54
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
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

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 108 110
Least Squares Mean (Standard Error) [mm/h]
-2.5
(1.30)
-1.8
(1.30)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.7003
Comments
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
21. Secondary Outcome
Title Change From Baseline in ESR at Week 12
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

Outcome Measure Data

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
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
Measure Participants 54 54 52 54
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
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

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 109 110
Least Squares Mean (Standard Error) [mg/L]
-4.16
(1.587)
-2.72
(1.600)
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 (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.5183
Comments
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
23. Secondary Outcome
Title Change From Baseline in CRP at Week 12
Description CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.
Time Frame Baseline, Week 12

Outcome Measure Data

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
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
Measure Participants 53 55 53 54
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
Description Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6
Time Frame Week 6

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 120 120
Number [percentage of participants]
2.5
2.1%
0.0
0%
25. Secondary Outcome
Title Percentage of Days With Concomitant Administration of Paracetamol
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

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 120 120
Mean (Standard Deviation) [percentage of days]
0.1
(0.08)
0.0
(0.00)
26. Secondary Outcome
Title Paracetamol Tablets Taken Per Day by Participant
Description Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.
Time Frame Week 6

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title Celecoxib 200 mg Diclofenac SR 75 mg
Arm/Group Description Celecoxib 200 mg capsule once daily Diclofenac SR 75 mg tablet once daily
Measure Participants 120 120
Mean (Standard Deviation) [tablets per day]
0.2
(0.16)
0.0
(0.00)

Adverse Events

Time Frame
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
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/120 (0%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Other (Not Including 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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 11/120 (9.2%) 9/120 (7.5%) 0/54 (0%) 6/55 (10.9%) 5/53 (9.4%) 6/54 (11.1%)
Blood and lymphatic system disorders
Anaemia 0/120 (0%) 0/120 (0%) 0/54 (0%) 1/55 (1.8%) 0/53 (0%) 0/54 (0%)
Leukopenia 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Cardiac disorders
Wolff-Parkinson-White Syndrome 0/120 (0%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Eye disorders
Uveitis 0/120 (0%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Gastrointestinal disorders
Abdominal discomfort 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Abdominal pain 0/120 (0%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 1/54 (1.9%)
Abdominal pain upper 1/120 (0.8%) 2/120 (1.7%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Dyspepsia 0/120 (0%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Epigastric discomfort 0/120 (0%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Mouth ulceration 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Hepatobiliary disorders
Hepatic function abnormal 0/120 (0%) 2/120 (1.7%) 0/54 (0%) 1/55 (1.8%) 0/53 (0%) 1/54 (1.9%)
Infections and infestations
Bronchitis 0/120 (0%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 1/53 (1.9%) 0/54 (0%)
Gastroenteritis 0/120 (0%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Upper respiratory tract infection 4/120 (3.3%) 1/120 (0.8%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 2/54 (3.7%)
Investigations
Alanine aminotransferase increased 0/120 (0%) 0/120 (0%) 0/54 (0%) 2/55 (3.6%) 1/53 (1.9%) 2/54 (3.7%)
Aspartate aminotransferase increased 0/120 (0%) 0/120 (0%) 0/54 (0%) 1/55 (1.8%) 0/53 (0%) 0/54 (0%)
Red blood cell urine positive 0/120 (0%) 0/120 (0%) 0/54 (0%) 1/55 (1.8%) 0/53 (0%) 0/54 (0%)
Transaminases increased 0/120 (0%) 0/120 (0%) 0/54 (0%) 1/55 (1.8%) 1/53 (1.9%) 0/54 (0%)
Weight decreased 0/120 (0%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 1/53 (1.9%) 0/54 (0%)
White blood cell count decreased 0/120 (0%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 1/53 (1.9%) 0/54 (0%)
Musculoskeletal and connective tissue disorders
Back pain 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Nervous system disorders
VIIth nerve paralysis 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)
Skin and subcutaneous tissue disorders
Rash generalised 1/120 (0.8%) 0/120 (0%) 0/54 (0%) 0/55 (0%) 0/53 (0%) 0/54 (0%)

Limitations/Caveats

The protocol does not specify time points for secondary endpoints; these are described in the statistical analysis plan.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00762463
Other Study ID Numbers:
  • A3191348
First Posted:
Sep 30, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021