Condition category
Musculoskeletal Diseases
Date applied
09/05/2002
Date assigned
09/05/2002
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sean Curtis

ORCID ID

Contact details

Merck & Co Inc
126 E Lincoln Avenue
Rahway
NJ 07065
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

025

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Each site received the approval of its Ethics Review Committee or Institutional Review Board to perform the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

1. Etoricoxib 90 mg once daily, naproxen 500 mg twice daily
2. Placebo for 12 weeks

Intervention type

Drug

Phase

Not Specified

Drug names

Etoricoxib, naproxen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1999

Overall trial end date

01/06/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with rheumatoid arthritis
2. Aged greater than or equal to 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

891

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/11/1999

Recruitment end date

01/06/2000

Locations

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Costa Rica, France, Germany, Greece, Hong Kong, Israel, Italy, Lithuania, Mexico, New Zealand, Peru, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States of America, Venezuela

Trial participating centre

Merck & Co Inc
Rahway
NJ 07065
United States of America

Sponsor information

Organisation

Merck & Co Inc (USA)

Sponsor details

126 E Lincoln Avenue
Rahway
NJ 07065
United States of America

Sponsor type

Industry

Website

http://www.merck.com

Funders

Funder type

Industry

Funder name

Merck & Co Inc (USA)

Alternative name(s)

Merck & Co., Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12033987

Publication citations

  1. Results

    Collantes E, Curtis SP, Lee KW, Casas N, McCarthy T, Melian A, Zhao PL, Rodgers DB, McCormick CL, Lee M, Lines CR, Gertz BJ, , A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273]., BMC Fam Pract, 2002, 3, 10.

Additional files

Editorial Notes