Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440661
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : March 4, 2010
Information provided by:
Laboratoires NEGMA

Brief Summary:
Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Diacerhein Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.
Study Start Date : March 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Synovial concentration of IL-1

Secondary Outcome Measures :
  1. Synovial concentration of IL-6
  2. WOMAC

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Painful osteoarthritis
  • Hydarthrosis (synovial effusion)

Exclusion Criteria:

  • large effusion
  • severe pathologies
  • anti-osteoarthritic treatments

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 identifier (NCT number): NCT00440661

Canada, Quebec
Rheumatologic Institut of Montreal
Montreal, Quebec, Canada, H2L1S6
Sponsors and Collaborators
Laboratoires NEGMA
Principal Investigator: Jean-Pierre RAYNAULD, MD Institut de Rhumatologie de Montreal

Responsible Party: Patrick Darses, Negma-Lerads Identifier: NCT00440661     History of Changes
Other Study ID Numbers: HEC/ART06572N
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: October 2007

Keywords provided by Laboratoires NEGMA:
Osteoarthritis, IL-1

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Anti-Inflammatory Agents