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Trial record 1 of 1 for:    NCT00762463
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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

Tracking Information
First Submitted Date  ICMJE September 29, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE June 17, 2011
Results First Posted Date  ICMJE August 23, 2011
Last Update Posted Date August 23, 2011
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
the change in Global Pain Intensity from baseline to Week 6 [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
  • Change in ankylosing spondylitis (ASAS) 20 response at 2, 4, 6 weeks relative to baseline [ Time Frame: 2-6 weeks ]
  • Change in Subjects' global pain intensity at Week 2, 4 relative to baseline [ Time Frame: 2-4 weeks ]
  • Change in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 2, 4, 6 relative to baseline [ Time Frame: 2-6 weeks ]
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 2, 4, 6 relative to baseline [ Time Frame: 2-6 weeks ]
  • Change in Patient's Global Assessment of Disease Activity at Week 2, 4, 6 relative to baseline [ Time Frame: 2-6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: Celecoxib
    capsule, 200 mg QD, 6-12 weeks
  • Drug: Diclofenac SR
    tablet, 75 mg QD,6-12 weeks
Study Arms  ICMJE
  • Experimental: Celecoxib 200 mg QD
    Intervention: Drug: Celecoxib
  • Active Comparator: Diclofenac SR 75 mg QD
    Intervention: Drug: Diclofenac SR
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2009)
240
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2008)
420
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762463
Other Study ID Numbers  ICMJE A3191348
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP