Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
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 A C A Marijnissen

ORCID ID

Contact details

UMC Utrecht
Rheumatology & Clin. Immunology
F02.127
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9758
a.c.a.marijnissen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR159

Study information

Scientific title

Selective COX-2 inhibition is beneficial for matrix turnover: a clinical study

Acronym

Study hypothesis

Selective COX-2 inhibition is beneficial for matrix turnover.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis

Intervention

Celecoxib: 4 weeks, 2 times per day, 200 mg
Naproxen: 4 weeks, 3 times per day, 250 mg
Indomethacin: 4 weeks, 2 times per day, 50 mg

Intervention type

Drug

Phase

Not Applicable

Drug names

Celecoxib, naproxen, indomethacin

Primary outcome measures

Difference in proteoglycan release of osteoarthritic cartilage after treatment

Secondary outcome measures

Prosteoglandin E2 levels produced by cartilage

Overall trial start date

01/11/2004

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria, considered for total knee replacement surgery.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

42

Participant exclusion criteria

1. Total knee replacement for other reason than osteoarthritis
2. History of gastro-intestinal bleedings or perforation
3. Increased risk for cardiovascular diseases (cardiovascular diseases in history, patients with untreated hypertension, patients with angina pectoris, and patients on oral anticoagulants)

Recruitment start date

01/11/2004

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

UMC Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Publication citations

Additional files

Editorial Notes