A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
NCT ID: NCT02528201
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
330 participants
INTERVENTIONAL
2002-09-30
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Celecoxib 200 milligrams mg QD
celecoxib 200 milligrams (mg) once a day (QD)
Celecoxib 200 milligrams
Celecoxib 200 milligrams once a day
Celexocib 400 mg QD
celecoxib 400 milligrams (mg) once a day (QD)
Celecoxib 400 milligrams
Celecoxib 400 milligrams once a day
Diclofenac 50 mg TID
diclofenac 50 milligrams (mg) three times a day (TID)
diclofenac 50 milligrams
diclofenac 50 milligrams three times a day
Interventions
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Celecoxib 200 milligrams
Celecoxib 200 milligrams once a day
Celecoxib 400 milligrams
Celecoxib 400 milligrams once a day
diclofenac 50 milligrams
diclofenac 50 milligrams three times a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ålesund sykehus
Ålesund, , Norway
Bekkestua legesenter
Bekkestua, , Norway
Dr. Johannessen Kontor
Bergen, , Norway
Dr.Wiigs kontor
Bergen, , Norway
Nordland Medisinske Senter
Bodø, , Norway
Martina Hansens hospital
Bærum Postterminal, , Norway
Sykehuset Buskerud HF
Drammen, , Norway
Lægene på Kongens torv
Gamle Fredrikstad, , Norway
Centre For Clinical Trials
Hamar, , Norway
Harstad sykehus
Harstad, , Norway
Haugesund sanitetsforenings revmatismesykehus
Haugesund, , Norway
Horten legesenter
Horten, , Norway
Solli Klinikk AS
Jessheim, , Norway
Kongsvinger sykehus HF
Kongsvinger, , Norway
Vest-Agder sentralsykehus
Kristiansand, , Norway
Dr. Svensens kontor
Kristiansand, , Norway
Lensbygda Legekontor
Lena, , Norway
Helse Nord-Trøndelag HF, Sykehuset Levanger
Levanger, , Norway
LSF Reumatismesykehus
Lillehammer, , Norway
Helgelandssykehuset HF
Mo i Rana, , Norway
Rikshospitalet
Oslo, , Norway
Økernlegene
Oslo, , Norway
Diakonhjemmet Hospital
Oslo, , Norway
Betanien Hospital
Skien, , Norway
Rosten legesenter
Tiller, , Norway
Universitetssykehuset Nord-Norge HF
Tromsø, , Norway
St.Olavs Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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A3191099
Identifier Type: OTHER
Identifier Source: secondary_id
COXA-0508-247
Identifier Type: -
Identifier Source: org_study_id
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