A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF 90 MG ETORICOXIB ONCE A DAY COMPARED WITH 75 MG SODIUM DICLOFENACO TWICE A DAY IN PATIENTS WITH RHEUMATOID ARTHRITIS.
Not Applicable
- Conditions
- M06-M06
- Registration Number
- PER-011-03
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a. The patient is a male or a woman at least 50 years old.
b. The patient has a clinical diagnosis of rheumatoid arthritis (must have met at least 4 of 7 revised criteria of the 1987 ARA at some time in the past) and the investigator will require a chronic therapy with NSAIDs or a selective COX-2 inhibitor .
c. The patient understands the study procedures and agrees to participate in the
study, through written informed consent.
Exclusion Criteria
a. The patient has a functional Class IV diagnosis according to the American
College of Rheumatology (ACR).
b. The patient has a concurrent medical or rheumatic disease that could
confuse or interfere with the evaluation of effectiveness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Global Assessment of the Condition of the Disease by the Patient<br>Measure:Global Assessment of Disease by the patient at each study visit for each patient.<br>Timepoints:1, 4, 8 and 12 months of therapy.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Adverse events reported spontaneously, physical exams, vital signs (blood pressure and heart rate) and laboratory safety measurements (hematology and serum chemistry) and ECG.<br>Measure:Gastrointestinal tolerability defined as the cumulative incidence of discontinuations due to clinical or laboratory gastrointestinal adverse events.<br>Timepoints:1, 4, 8 and 12 months of therapy.<br>