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Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Laboratoires NEGMA
ClinicalTrials.gov Identifier:
NCT00445276
First received: March 6, 2007
Last updated: March 3, 2010
Last verified: March 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Laboratoires NEGMA:

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
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  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
Laboratoires NEGMA
Investigators
Principal Investigator: Jean - Pierre Valat Unafilliated
  More Information

No publications provided

Responsible Party: Patrick Darses, Negam-Lerads
ClinicalTrials.gov Identifier: NCT00445276     History of Changes
Other Study ID Numbers: HEC / ART 05 566 N, AFSSAPS:050984, CCPPRB:2005-27
Study First Received: March 6, 2007
Last Updated: March 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires NEGMA:
Osteoarthritis
Knee
Diacerein
Painful osteoarthritis
Clinical trial

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Diacetylrhein
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013