|
ISRCTN
|
ISRCTN55717501
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Efficacy of the treatment with a COX-2 specific inhibitor celecoxib in osteoarthritic patients
|
|
Scientific title
|
|
|
Acronym
|
COXOA
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Our hypothesis is that celecoxib could have a specific antiinflammatory profile to that of a classic antiinflammatory treatment on patients with knee osteoarthritis (OA).
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Spain
|
|
Disease/condition/study domain
|
Advanced osteoarthritis
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Pregnancy, gastrointestinal pathology, kidney or hepatic insufficiency, diabetes, cardiovascular disease, oncologic patients.
|
|
Anticipated start date
|
12/02/2002
|
|
Anticipated end date
|
12/02/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
30
|
|
Interventions
|
Comparison of celecoxib treatment versus aceclofenac treatment
|
|
Primary outcome measure(s)
|
Synovial inflammation markers on the synovial membrane of osteoarthritis patients
|
|
Secondary outcome measure(s)
|
Effect on Western Ontario McMaster Universities Osteoarthritis (WOMAC) index
|
|
Sources of funding
|
Mapfre Medicina Foundation (grant 2003), Spanish Ministery of Education (SAF 08/0379), Fondo de Investigaciones Sanitarias (CP03/00011), Pfizer Spain
|
|
Trial website
|
|
|
Publications
|
2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18547825
|
|
Contact name
|
Dr
Javier
Santillana
|
|
Address
|
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
|
|
City/town
|
Tortosa - Tarragona
|
|
Zip/Postcode
|
43500
|
|
Country
|
Spain
|
|
Tel
|
+34 977519133
|
|
Fax
|
+34 977519200
|
|
Email
|
jsanmher@eresmas.com
|
|
Sponsor
|
Hospital de Tortosa Virgen de la Cinta (Spain)
|
|
Address
|
Javier Santillana
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
|
|
City/town
|
Tortosa - Tarragona
|
|
Zip/Postcode
|
43500
|
|
Country
|
Spain
|
|
Tel
|
+34 977519133
|
|
Fax
|
+34 977519200
|
|
Email
|
jsanmher@eresmas.com
|
|
Date applied
|
06/07/2005
|
|
Last edited
|
02/10/2008
|
|
Date ISRCTN assigned
|
08/07/2005
|
