Symptomatic Efficacy of Diacerein in Knee Osteoarthritis - Full Text View

Purpose

Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.

Condition	Intervention	Phase
Knee Osteoarthritis	Drug: Diacerein	Phase IV

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Diacerein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

Further study details as provided by Negma Lerads:

Primary Outcome Measures:

VAS on pain movement, WOMAC A 1.1 section

Secondary Outcome Measures:

WOMAC : total, pain, physical function
Paracetamol consumption
Global assessment of the patient
Responder patients with OMERACT-OARSI criteria
Tolerance

Estimated Enrollment:	500
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Painful primary osteoarthritis (VAS ≥ 40 mm)
Radiologically proven (Kellgren & Lawrence grade I to III)
Requiring the prescription of a symptomatic treatment of pain

Exclusion Criteria:

Severe associated diseases
Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
Other osteoarticular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445276

Locations


France
	Chu Trousseau
	Tours, France, 37044

Sponsors and Collaborators

Negma Lerads

Investigators


Principal Investigator:	Jean - Pierre Valat	Unafilliated

More Information

Study ID Numbers:	HEC / ART 05 566 N, AFSSAPS:050984, CCPPRB:2005-27
First Received:	March 6, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00445276
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Negma Lerads:

Osteoarthritis

Knee

Diacerein

Painful osteoarthritis

Clinical trial

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Pain

Rheumatic Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Negma Lerads
Information provided by:	Negma Lerads
ClinicalTrials.gov Identifier:	NCT00445276