A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis

• 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

• 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

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).