A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: June 17, 2015
Last verified: June 2015
A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: MK0966; rofecoxib
Drug: Comparator: naproxen tablet 500 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Tender joint count
  • swollen joint count
  • patient's global assessment of disease activity
  • investigator's global assessment of disease activity

Secondary Outcome Measures:
  • Patient pain assessment
  • patient's global assessment of response to therapy
  • investigator's global assessment of response to therapy

Estimated Enrollment: 150
Study Start Date: January 2004
Study Completion Date: September 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chinese males or females at least 18 years of age with rheumatoid arthritis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00157872

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157872     History of Changes
Other Study ID Numbers: 0966-231, 2005_063
Study First Received: September 7, 2005
Last Updated: June 17, 2015
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on December 01, 2015