The direct effects of non-steroidal anti-inflammatory drugs (NSAIDS) on osteoarthritic knee cartilage
| ISRCTN | ISRCTN90366351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90366351 |
| Secondary identifying numbers | NTR159 |
- 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
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Celecoxib, naproxen, indomethacin |
| Primary outcome measure | Difference in proteoglycan release of osteoarthritic cartilage after treatment |
| Secondary outcome measures | Prosteoglandin E2 levels produced by cartilage |
| Overall study start date | 01/11/2004 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
PO Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
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 |
