Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445276
• Other study ID #: HEC / ART 05 566 N
• Secondary ID: AFSSAPS:050984CC
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2007
• Last updated: March 3, 2010
• Start date: November 2005
• Est. completion date: September 2006

Study information

• Verified date: March 2010
• Source: Laboratoires NEGMA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diacerein

Locations

Country	Name	City	State
France	Chu Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires NEGMA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS on pain movement, WOMAC A 1.1 section
Secondary	WOMAC : total, pain, physical function
Secondary	Paracetamol consumption
Secondary	Global assessment of the patient
Secondary	Responder patients with OMERACT-OARSI criteria
Secondary	Tolerance