Condition category
Musculoskeletal Diseases
Date applied
06/07/2005
Date assigned
08/07/2005
Last edited
02/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18547825

Publication citations

  1. 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.

Additional files

Editorial Notes