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Completed

NCT Number: NCT00762463

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

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).

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

capsule, 200 mg QD, 6-12 weeks

Diclofenac SR

Drug

tablet, 75 mg QD,6-12 weeks

Primary outcomes

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

    Time frame: Baseline, Week 6

    100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement.

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

    Time frame: 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 outcomes

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

    Time frame: Baseline, Weeks 2, 4

    100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement.

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

    Time frame: Baseline, Week 12

    100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Week 12

    5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Week 12

    5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.

  8. Change From Baseline in BASFI at Week 12

    Time frame: Baseline, Week 12

    BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.

  10. Change From Baseline in BASDAI at Week 12

    Time frame: Baseline, Week 12

    BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.

  11. Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20

    Time frame: Weeks 2, 4, 6, 12

    Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).

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

    Time frame: Baseline, Weeks 2, 4, 6

    100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement.

  13. Change From Baseline in Nocturnal Pain at Week 12

    Time frame: Baseline, Week 12

    100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, Week 12

    Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.

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

    Time frame: Baseline, Weeks 2, 4, 6

    Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.

  17. Change From Baseline in Chest Expansion at Week 12

    Time frame: Baseline, Week 12

    Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.

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

    Time frame: Baseline, Week 6

    Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.

  19. Change From Baseline in ESR at Week 12

    Time frame: Baseline, Week 12

    ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.

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

    Time frame: Baseline, 6 Weeks

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

  21. Change From Baseline in CRP at Week 12

    Time frame: Baseline, Week 12

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

  22. Percentage of Participants With Concomitant Use of Paracetamol

    Time frame: Week 6

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

  23. Percentage of Days With Concomitant Administration of Paracetamol

    Time frame: Week 6

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

  24. Paracetamol Tablets Taken Per Day by Participant

    Time frame: Week 6

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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