Official Title: “A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis”

A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: MK0966; rofecoxib
• Drug: Comparator: naproxen tablet 500 mg

Primary Measures

• Tender joint count
• swollen joint count
• patient's global assessment of disease activity
• investigator's global assessment of disease activity

Secondary Measures

• Patient pain asessment
• patient's global assessment of response to therapy
• investigator's global assessment of response to therapy

Inclusion Criteria:

• Chinese males or females at least 18 years of age with rheumatoid arthritis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00157872

Study ID Number: 2005_063

ClinicalTrials.gov Identifier: NCT00157872

Health Authority: China: Ministry of Health