Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0663, etoricoxib

Drug

Comparator: Diclofenac sodium

Drug

Primary outcomes

Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Sep 28, 2004
Registry last updated: Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed