Multinational randomised controlled clinical trial of etoricoxib in the treatment of rheumatoid arthritis
| ISRCTN | ISRCTN25142273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25142273 |
| Secondary identifying numbers | 025 |
- Submission date
- 09/05/2002
- Registration date
- 09/05/2002
- Last edited
- 15/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Sean Curtis
Scientific
Scientific
Merck & Co Inc
126 E Lincoln Avenue
Rahway
NJ 07065
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Each site received the approval of its Ethics Review Committee or Institutional Review Board to perform the study. |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 1. Etoricoxib 90 mg once daily, naproxen 500 mg twice daily 2. Placebo for 12 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Etoricoxib, naproxen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/1999 |
| Completion date | 01/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 891 |
| Key inclusion criteria | 1. Patients with rheumatoid arthritis 2. Aged greater than or equal to 18 years |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/11/1999 |
| Date of final enrolment | 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
- Türkiye
- United Kingdom
- United States of America
- Venezuela
Study participating centre
Merck & Co Inc
Rahway
NJ 07065
United States of America
NJ 07065
United States of America
Sponsor information
Merck & Co Inc (USA)
Industry
Industry
126 E Lincoln Avenue
Rahway
NJ 07065
United States of America
| Website | http://www.merck.com |
|---|
Funders
Funder type
Industry
Merck & Co Inc (USA)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Merck & Co., Inc., Merck & Co.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/05/2002 | Yes | No |
