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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Celecoxib
Diclofenac SR
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Celecoxib 200 mg QD

Diclofenac SR 75 mg QD

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Participant's Assessment of Global Pain Intensity at 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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.

Full Information

First Posted
September 29, 2008
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00762463
Brief Title
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib 200 mg QD
Arm Type
Experimental
Arm Title
Diclofenac SR 75 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
capsule, 200 mg QD, 6-12 weeks
Intervention Type
Drug
Intervention Name(s)
Diclofenac SR
Intervention Description
tablet, 75 mg QD,6-12 weeks
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Pfizer Investigational Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Pfizer Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25516774
Citation
Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191348&StudyName=Study%20Of%20Celecoxib%20Or%20Diclofenac%20For%20Efficacy%20and%20Safety%20In%20Chinese%20Patients%20With%20Ankylosing%20Spondylitis
Description
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Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

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