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Basic & Clinical ResearchFor Rheumatoid Arthritis A Double-Blind, Placebo-Controlled Study of the Effect of MK-0966 on Blood and Synovial Fluid Prostaglandin Levels and Synovial Fluid MK-0966 concentration in Patients with Rheumatoid Arthritis Objective:
1. To evaluate and compare the effects of MK-0966, diclofenac, and placebo on synovial fluid PGE-2 in patients with RA Inclusion Criteria: M/F OVER 18 YEARS OF AGE with dx. of RA for at least 6 months and not before age 16;WEIGHING NO MORE THAN 127 kgMay take NSAIDs but must d/c during a washout period (this includes ASA) May take low-dose oral corticosteroids ( 10 mg per day of prednisone or equivalent) provided the patient has been taking the dose for the past 3 months and the dose has been stable for the previous 1 month The patient must have a KNEE EFFUSION, which is a manifestation of the RA and not due to recent mechanical trauma. The knee effusion must be of sufficient volume to permit repeat aspiration of at least 3 ml. of synovial fluid. Exclusion Criteria: NO other concurrent inflammatory arthropathy that could confound or interfere with synovial fluid prostaglandin analysisNO active sxs of gastritis or ulcer; NO past hx of gastric, small intestine or hepatobiliary surgery that has resulted in clinical malabsorption NO serum creatinine greater than 2mg/dL. NO uncontrolled HTN NO hx of CAD with active angina or hx CHF NO hx of hepatic disease/hepatitis that has been clinically active within the past 2 years NO hx of leukemia, lymphoma, or myeloproliferative disease NO intra-articular, intramuscular, or intravenous corticosteroids within 4 weeks; NO intra-articular steroids to the effused knee within 3 months NO ASA, ACETAMINOPHEN, NSAIDs, CYCLOSPORINE, SULFASALAZINE, MISOPROSTOL, WARFARIN AND TICLOPIDINE DURING THE ENTIRE STUDY PERIOD. IF TAKING ANY OF THESE MEDS, THEY WILL D/C 4 WEEKS PRIOR TO ENROLLMENT & CAN BE RESTARTED AFTER THE SECOND KNEE ASPIRATION ***PATIENTS WILL RECEIVE $250 PLUS TRANSPORTAION MONEY FOR PARTICIPATION***
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