A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis...
Date First Received: September 7, 2005
Last Updated: November 30, 2006
Verified by: Merck, November 2006
Clinical Trial Phase: Phase 4 | Start Date: February 2004
Overall Status: Terminated
Estimated Enrollment: 150
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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
Outcome Measures for this Clinical Trial
Primary:
- Tender joint count
- swollen joint count
- patient's global assessment of disease activity
- investigator's global assessment of disease activity
Secondary:
- Patient pain asessment
- patient's global assessment of response to therapy
- investigator's global assessment of response to therapy
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Chinese males or females at least 18 years of age with rheumatoid arthritis
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Merck
Merck Sharp & Dohme (China) Ltd.
Beijing 100738 China
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
