Back to resultsA Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0966; rofecoxib
Comparator: naproxen tablet 500 mg
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Chinese males or females at least 18 years of age with rheumatoid arthritis
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00157872
First Posted
September 7, 2005
Last Updated
May 23, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00157872
Brief Title
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 7, 2004 (Actual)
Primary Completion Date
July 5, 2004 (Actual)
Study Completion Date
September 19, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A study to compare rofecoxib versus naproxen in the treatment of Chinese patients with rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0966; rofecoxib
Intervention Type
Drug
Intervention Name(s)
Comparator: naproxen tablet 500 mg
Primary Outcome Measure Information:
Title
Tender joint count
Title
swollen joint count
Title
patient's global assessment of disease activity
Title
investigator's global assessment of disease activity
Secondary Outcome Measure Information:
Title
Patient pain assessment
Title
patient's global assessment of response to therapy
Title
investigator's global assessment of response to therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese males or females at least 18 years of age with rheumatoid arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)
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