A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Celecoxib 200 milligrams (Drug); Celecoxib 400 milligrams (Drug); diclofenac 50 milligrams (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing Spondylitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
Secondary outcome: Participants Global Assessment of Pain Intensity (VAS)Bath Ankylosing Spondylitis Functional Index (BASFI) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Participants and Physicians Global Assessment of Disease Activity Participants and Physicians Global Assessment of Treatment Participants Consumption of Rescue Medication
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Bekkestua legesenter, Bekkestua 1357, Norway
Dr. Johannessen Kontor, Bergen 5004, Norway
Dr.Wiigs kontor, Bergen 5838, Norway
Nordland Medisinske Senter, Bodø 8006, Norway
Martina Hansens hospital, Bærum Postterminal 1306, Norway
Sykehuset Buskerud HF, Drammen 3004, Norway
Lægene på Kongens torv, Gamle Fredrikstad 1632, Norway
Centre For Clinical Trials, Hamar 2300, Norway
Harstad sykehus, Harstad 9480, Norway
Haugesund sanitetsforenings revmatismesykehus, Haugesund 5513, Norway
Horten legesenter, Horten 3188, Norway
Solli Klinikk AS, Jessheim 2050, Norway
Kongsvinger sykehus HF, Kongsvinger 2226, Norway
Dr. Svensens kontor, Kristiansand 4610, Norway
Vest-Agder sentralsykehus, Kristiansand 4604, Norway
Lensbygda Legekontor, Lena 2850, Norway
Helse Nord-Trøndelag HF, Sykehuset Levanger, Levanger 7600, Norway
LSF Reumatismesykehus, Lillehammer 2609, Norway
Helgelandssykehuset HF, Mo I Rana 8607, Norway
Diakonhjemmet Hospital, Oslo N-0319, Norway
Rikshospitalet, Oslo 0027, Norway
Økernlegene, Oslo 0580, Norway
Betanien Hospital, Skien 3722, Norway
Rosten legesenter, Tiller 7092, Norway
Universitetssykehuset Nord-Norge HF, Tromsø 9038, Norway
St.Olavs Hospital, Trondheim 7006, Norway
Ålesund sykehus, Ålesund 6026, Norway
Additional Information
Starting date: September 2002
Last updated: August 18, 2015
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