Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
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
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
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
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.- A3191348
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
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 |
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)
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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 |
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)
|
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%
|
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)
|
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
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 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A3191348