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

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ClinicalTrials.gov Identifier: NCT00092742
Recruitment Status : Completed
First Posted : September 28, 2004
Last Update Posted : June 30, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MK0663, etoricoxib Drug: Comparator: Diclofenac sodium Phase 3

Detailed Description:
The duration of treatment is 12 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2003
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Discontinuations due to clinical and laboratory gastrointestinal adverse experiences

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092742

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092742     History of Changes
Other Study ID Numbers: 0663-072
First Posted: September 28, 2004    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors