Contact information
Type
Scientific
Primary contact
Dr Javier Santillana
ORCID ID
Contact details
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
Tortosa - Tarragona
43500
Spain
+34 977519133
jsanmher@eresmas.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
COXOA
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Advanced osteoarthritis
Intervention
Comparison of celecoxib treatment versus aceclofenac treatment
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
12/02/2002
Overall trial end date
12/02/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Pregnancy, gastrointestinal pathology, kidney or hepatic insufficiency, diabetes, cardiovascular disease, oncologic patients.
Recruitment start date
12/02/2002
Recruitment end date
12/02/2003
Locations
Countries of recruitment
Spain
Trial participating centre
Orthopaedic Department
Tortosa - Tarragona
43500
Spain
Sponsor information
Organisation
Hospital de Tortosa Virgen de la Cinta (Spain)
Sponsor details
Javier Santillana
Orthopaedic Department
Hospital de Tortosa Virgen de la Cinta
Esplanetes 47
Tortosa - Tarragona
43500
Spain
+34 977519133
jsanmher@eresmas.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Mapfre Medicina Foundation (grant 2003), Spanish Ministery of Education (SAF 08/0379), Fondo de Investigaciones Sanitarias (CP03/00011), Pfizer Spain
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18547825
Publication citations
-
Results
Alvarez-Soria MA, Herrero-Beaumont G, Moreno-Rubio J, Calvo E, Santillana J, Egido J, Largo R, Long-term NSAID treatment directly decreases COX-2 and mPGES-1 production in the articular cartilage of patients with osteoarthritis., Osteoarthr. Cartil., 2008, 16, 12, 1484-1493, doi: 10.1016/j.joca.2008.04.022.