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Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00445276
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : March 4, 2010
Sponsor:
Information provided by:
Laboratoires NEGMA

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Diacerein Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
Study Start Date : November 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




Primary Outcome Measures :
  1. VAS on pain movement, WOMAC A 1.1 section

Secondary Outcome Measures :
  1. WOMAC : total, pain, physical function
  2. Paracetamol consumption
  3. Global assessment of the patient
  4. Responder patients with OMERACT-OARSI criteria
  5. Tolerance


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445276


Locations
France
Chu Trousseau
Tours, France, 37044
Sponsors and Collaborators
Laboratoires NEGMA
Investigators
Principal Investigator: Jean - Pierre Valat Unafilliated

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
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: March 2010

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