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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157872

Enrollment

150

Registered

2005-09-12

Start date

2004-01-07

Completion date

2004-09-19

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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

Interventions

DRUGMK0966; rofecoxib

DRUGComparator: naproxen tablet 500 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Tender joint count	—
swollen joint count	—
patient's global assessment of disease activity	—
investigator's global assessment of disease activity	—

Secondary

Measure	Time frame
patient's global assessment of response to therapy	—
investigator's global assessment of response to therapy	—
Patient pain assessment	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026