NCT00157872

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_4 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

September 7, 2005

Last Update Submit

May 23, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • Tender joint count

  • swollen joint count

  • patient's global assessment of disease activity

  • investigator's global assessment of disease activity

Secondary Outcomes (3)

  • Patient pain assessment

  • patient's global assessment of response to therapy

  • investigator's global assessment of response to therapy

Interventions

MK0966; rofecoxibDRUG
Comparator: naproxen tablet 500 mgDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

January 7, 2004

Primary Completion

July 5, 2004

Study Completion

September 19, 2004

Last Updated

May 25, 2017

Record last verified: 2017-05