Efficacy of the treatment with a COX-2 specific inhibitor celecoxib in osteoarthritic patients
| ISRCTN | ISRCTN55717501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55717501 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/07/2005
- Registration date
- 08/07/2005
- Last edited
- 02/10/2008
- 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
Dr Javier Santillana
Scientific
Scientific
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
Tortosa - Tarragona
43500
Spain
| Phone | +34 977519133 |
|---|---|
| jsanmher@eresmas.com |
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 acronym | COXOA |
| Study objectives | Our hypothesis is that celecoxib could have a specific antiinflammatory profile to that of a classic antiinflammatory treatment on patients with knee osteoarthritis (OA). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Advanced osteoarthritis |
| Intervention | Comparison of celecoxib treatment versus aceclofenac treatment |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Celecoxib and aceclofenac |
| Primary outcome measure | Synovial inflammation markers on the synovial membrane of osteoarthritis patients |
| Secondary outcome measures | Effect on Western Ontario McMaster Universities Osteoarthritis (WOMAC) index |
| Overall study start date | 12/02/2002 |
| Completion date | 12/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Patients with clinical and radiological evidence of knee OA who met the American Rheumatism Association criteria for functional classes III or IV, who were scheduled for total knee replacement and who accepted to be treated with an antiinflammatory drug. |
| Key exclusion criteria | Pregnancy, gastrointestinal pathology, kidney or hepatic insufficiency, diabetes, cardiovascular disease, oncologic patients. |
| Date of first enrolment | 12/02/2002 |
| Date of final enrolment | 12/02/2003 |
Locations
Countries of recruitment
- Spain
Study participating centre
Orthopaedic Department
Tortosa - Tarragona
43500
Spain
43500
Spain
Sponsor information
Hospital de Tortosa Virgen de la Cinta (Spain)
Hospital/treatment centre
Hospital/treatment centre
Javier Santillana
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
Tortosa - Tarragona
43500
Spain
| Phone | +34 977519133 |
|---|---|
| jsanmher@eresmas.com | |
"ROR" |
https://ror.org/046sqxa62 |
Funders
Funder type
Industry
Mapfre Medicina Foundation (grant 2003), Spanish Ministery of Education (SAF 08/0379), Fondo de Investigaciones Sanitarias (CP03/00011), Pfizer Spain
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
