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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157872
• Other study ID #: 0966-231
• Secondary ID: 2005_063
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: May 23, 2017
• Start date: January 7, 2004
• Est. completion date: September 19, 2004

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 19, 2004
• Est. primary completion date: July 5, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MK0966; rofecoxib

• Comparator: naproxen tablet 500 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tender joint count
Primary	swollen joint count
Primary	patient's global assessment of disease activity
Primary	investigator's global assessment of disease activity
Secondary	Patient pain assessment
Secondary	patient's global assessment of response to therapy
Secondary	investigator's global assessment of response to therapy