A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
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A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age greater than or equal to 18 and less than or equal to 80
Diagnosis of Rheumatoid Arthritis for at least six weeks
Taking an NSAID
If female: using adequate contraception
Willingness to stop current NSAID until criteria reached to begin study drug
Able to provide written informed consent
Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
Use of investigational drug within 30 days prior to entering the trial
History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
History of cerebrovascular or other bleeding disorder
Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
RA of functional class IV
Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
DMARDs initiated within past three months or dose changed less than two months before entering the trial
Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
Concomitant therapy with ACTH within past month before entering the trial.
History of narcotic or alcohol abuse (past 12 months)