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Trial record 1 of 1 for:    NCT02528201
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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02528201
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE September 2002
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12 [ Time Frame: Baseline, Week 12 ]
Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • Participants Global Assessment of Pain Intensity (VAS) [ Time Frame: Weeks 2, 6 ]
    Global Pain Intensity score (VAS): is a participant reported assessment of pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm= no pain and 100=most severe pain.
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Weeks 2, 6 ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Weeks 2, 6 ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10
  • Participants and Physicians Global Assessment of Disease Activity [ Time Frame: Weeks 2, 6, 12 ]
    Participants are asked at each visit the following questions: Taking everything into account how do you assess the activity of your disease in the last 2 days on a scale where: 0=disease inactive with no symptoms and 100=disease extremely active?
  • Participants and Physicians Global Assessment of Treatment [ Time Frame: Week 12 ]
    The patients will be asked up to four global questions about safety and efficacy of the trial medication and about their current disease status. Responses are done on a 5 point scale where 0=no effect, 1=poor effect, 2=moderate effect, 3=good effect, and 4=excellent. At the same visits the investigator will be asked to do his/her own judgment of the efficacy and tolerance of the treatment (excellent, good, moderate, poor).
  • Participants Consumption of Rescue Medication [ Time Frame: Baseline, Weeks 2, 6, 12 ]
    Participant consumption of rescue medication (paracetamol) calculated at each individual visit (except from the screening visit) by counting returned tablets versus tablets dispensed at the previous visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
Official Title  ICMJE A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis
Brief Summary A clinical trial to assess the effect of celecoxib 200 milligrams (mg) once daily and 400 milligrams (mg) once daily compared to diclofenac three times daily in the treatment of Ankylosing Spondylitis (AS) for 12 weeks. This will be used to confirm the results of a prior 6 week trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: Celecoxib 200 milligrams
    Celecoxib 200 milligrams once a day
  • Drug: Celecoxib 400 milligrams
    Celecoxib 400 milligrams once a day
  • Drug: diclofenac 50 milligrams
    diclofenac 50 milligrams three times a day
Study Arms  ICMJE
  • Active Comparator: Celecoxib 200 milligrams mg QD
    celecoxib 200 milligrams (mg) once a day (QD)
    Intervention: Drug: Celecoxib 200 milligrams
  • Active Comparator: Celexocib 400 mg QD
    celecoxib 400 milligrams (mg) once a day (QD)
    Intervention: Drug: Celecoxib 400 milligrams
  • Active Comparator: Diclofenac 50 mg TID
    diclofenac 50 milligrams (mg) three times a day (TID)
    Intervention: Drug: diclofenac 50 milligrams
Publications * Not Provided

*   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 18, 2015)
330
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 18 to 75 years of age, inclusive.
  • Clinical diagnosis of ankylosing spondylitis:
  • Willing to stop existing NSAID/COX-2 inhibitor treatment for up to two weeks.
  • Having given written informed consent to participate in the trial.
  • Pain intensity ≥ 40 mm on the visual analog scale, worsening by at least 30 % compared to that recorded at the screening visit.
  • Last administration of analgesic without anti-inflammatory activity is ≥ 8 h, the last administration of long-acting NSAIDs is ≥ 72 h

Exclusion Criteria:

  • Patients with acute peripheral articular disease (defined by the onset within 4 weeks prior to visit
  • Known inflammatory enteropathy (e.g. ulcerative colitis, Crohn's disease).
  • Ongoing extra-articular signs (e.g. cardiac involvement).
  • Current painful vertebral compression.
  • Requirement to start physiotherapy, re-education or manipulation
  • History of clinical gastroduodenal ulcer in the year preceding inclusion, confirmed by endoscopy; continuing gastro-intestinal bleeding.
  • Cardiac failure or known renal insufficiency that could be affected by study medication, chronic or acute hepatic insufficiency, significant coagulation disorders or history of asthma.
  • Current or history of malignancy (except: patients having a basal cell carcinoma or other malignancy operated on and in remission for 5 years before inclusion in the trial).
  • Pregnancy, women of childbearing potential not using adequate contraceptive methods or nursing mothers.
  • Subject who has evidence of alcohol or drug abuse.
  • Participation in any other clinical study within 30 days prior to the screening visit.
  • Any condition that would prevent the patient from entering the study, according to the investigator's judgment.
  • Known hypersensitivity to celecoxib, sulphonamides or any NSAID (including salicylic acid).
  • Taking the following medications: Muscle relaxants, hypnotic, anxiolytics, sedatives, tranquillizers or antidepressants (unless stable for 2 weeks before screening and continuing throughout the trial), NSAIDs or COX-2 inhibitors other than study medication, acetylsalicylic acid (ASA) > 160 mg /day, anti-coagulants, ticlopidine, lithium, anti-TNF agents or methotrexate > 15 mg/week (Note: ASA ≤ 160 mg/day for cardioprotection is permitted), Use of oral or systemic analgesic medication, except from paracetamol, within 3 days of study entry and through the study, Corticosteroids (PO/IM/IV/IA) in the 6 weeks preceding inclusion in the trial, Anti-ulcer medication including chronic (daily or almost daily) use of antacids [Note: Occasional use of antacids during the study will be permitted.]
  • Change in dose of a slow-acting drug (e.g. sulfasalazin, methotrexate) in the past 60 days preceding inclusion in the trial.
  • Taking paracetamol > 2000 mg/day (including during the screening period).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02528201
Other Study ID Numbers  ICMJE COXA-0508-247
A3191099 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2015

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