The direct effects of non-steroidal anti-inflammatory drugs (NSAIDS) on osteoarthritic knee cartilage
| ISRCTN | ISRCTN90366351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90366351 |
| Protocol serial number | NTR159 |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Funder | Not provided at time of registration |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A C A Marijnissen
Scientific
Scientific
UMC Utrecht
Rheumatology & Clin. Immunology, F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 9758 |
|---|---|
| a.c.a.marijnissen@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Selective COX-2 inhibition is beneficial for matrix turnover: a clinical study |
| Study objectives | Selective COX-2 inhibition is beneficial for matrix turnover. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Celecoxib: 4 weeks, 2 times per day, 200 mg Naproxen: 4 weeks, 3 times per day, 250 mg Indomethacin: 4 weeks, 2 times per day, 50 mg |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Celecoxib, naproxen, indomethacin |
| Primary outcome measure(s) |
Difference in proteoglycan release of osteoarthritic cartilage after treatment |
| Key secondary outcome measure(s) |
Prosteoglandin E2 levels produced by cartilage |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 42 |
| Key inclusion criteria | Patients with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria, considered for total knee replacement surgery. |
| Key exclusion criteria | 1. Total knee replacement for other reason than osteoarthritis 2. History of gastro-intestinal bleedings or perforation 3. Increased risk for cardiovascular diseases (cardiovascular diseases in history, patients with untreated hypertension, patients with angina pectoris, and patients on oral anticoagulants) |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
UMC Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
