A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug

• Pregnancy, lactating

• 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

• Severe hypertension

• 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)

• Abnormal laboratory values

• Previous participation in the present trial