ABOUT THIS STUDY
- 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
- 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
- Pregnancy, women of childbearing potential not using adequate contraceptive methods or
- 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
- Known hypersensitivity to celecoxib, sulphonamides or any NSAID (including salicylic
- 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).
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