Efficacy of the treatment with a COX-2 specific inhibitor celecoxib in osteoarthritic patients

ISRCTN	ISRCTN55717501
DOI	https://doi.org/10.1186/ISRCTN55717501
Protocol serial number	N/A
Sponsor	Hospital de Tortosa Virgen de la Cinta (Spain)
Funder	Mapfre Medicina Foundation (grant 2003), Spanish Ministery of Education (SAF 08/0379), Fondo de Investigaciones Sanitarias (CP03/00011), Pfizer Spain

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Javier Santillana
Scientific

Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
Tortosa - Tarragona
43500
Spain

Phone	+34 977519133
Email	jsanmher@eresmas.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Celecoxib and aceclofenac
Primary outcome measure(s)	Synovial inflammation markers on the synovial membrane of osteoarthritis patients
Key secondary outcome measure(s)	Effect on Western Ontario McMaster Universities Osteoarthritis (WOMAC) index
Completion date	12/02/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Orthopaedic Department

Tortosa - Tarragona
43500
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008		Yes	No