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 measure
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 (if study stopped)
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
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
For-profit companies (industry)
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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12033987
Publication citations
-
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.