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Trial record 94 of 299 for:    "Ankylosing spondylitis"

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

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

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
Ankylosing Spondylitis Drug: Celecoxib Drug: Diclofenac SR Phase 3

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


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762463


Locations
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China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510630
China, Shanxi
Pfizer Investigational Site
Xi'an, Shanxi, China, 710032
China, Sichuan
Pfizer Investigational Site
Chengdu, Sichuan, China, 610041
China
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Beijing, China, 100853
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00762463     History of Changes
Other Study ID Numbers: A3191348
First Posted: September 30, 2008    Key Record Dates
Results First Posted: August 23, 2011
Last Update Posted: August 23, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Celecoxib
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action