A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis

This study has been terminated.

First Received on September 7, 2005. Last Updated on November 30, 2006 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157872

Purpose

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Naproxen Naproxen sodium Rofecoxib

U.S. FDA Resources

Further study details as provided by Merck:

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 asessment
patient's global assessment of response to therapy
investigator's global assessment of response to therapy

Estimated Enrollment:	150
Study Start Date:	February 2004

Eligibility

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

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157872

Locations

China
Merck Sharp & Dohme (China) Ltd.
Beijing, China, 100738

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00157872 History of Changes
Other Study ID Numbers:	2005_063
Study First Received:	September 7, 2005
Last Updated:	November 30, 2006
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Naproxen
Rofecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012