A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis

Organon and Co0 sites4,086 target enrollmentFebruary 2003

ConditionsRheumatoid Arthritis

DrugsMK0663, etoricoxib Comparator: Diclofenac sodium

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Organon and Co
Enrollment: 4086
Primary Endpoint: Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.

Detailed Description

The duration of treatment is 12 months.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

December 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females 50 years or older with rheumatoid arthritis.

Exclusion Criteria

•History of gastrointestinal malabsorption or inflammatory bowel disease
•History of heart problems such as: congestive heart failure (CHF), heart attack or high blood pressure.