Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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31 August 2015 |
Main ID: |
NCT02528201 |
Date of registration:
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18/06/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
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Scientific title:
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A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis |
Date of first enrolment:
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September 2002 |
Target sample size:
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330 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02528201 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: diclofenac 50 milligrams
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Drug: Celecoxib 400 milligrams
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Drug: Celecoxib 200 milligrams
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Primary Outcome(s)
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Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
[Time Frame: Baseline, Week 12]
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Secondary Outcome(s)
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Participants and Physicians Global Assessment of Treatment
[Time Frame: Week 12]
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
[Time Frame: Weeks 2, 6]
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Bath Ankylosing Spondylitis Functional Index (BASFI)
[Time Frame: Weeks 2, 6]
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Participants Consumption of Rescue Medication
[Time Frame: Baseline, Weeks 2, 6, 12]
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Participants and Physicians Global Assessment of Disease Activity
[Time Frame: Weeks 2, 6, 12]
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Participants Global Assessment of Pain Intensity (VAS)
[Time Frame: Weeks 2, 6]
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Secondary ID(s)
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A3191099
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COXA-0508-247
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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