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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440661
First Posted: February 27, 2007
Last Update Posted: March 4, 2010
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.
Information provided by:
Laboratoires NEGMA
  Purpose
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 Intervention Phase
Osteoarthritis Drug: Diacerhein Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Laboratoires NEGMA:

Primary Outcome Measures:
  • Synovial concentration of IL-1

Secondary Outcome Measures:
  • Synovial concentration of IL-6
  • WOMAC

Estimated Enrollment: 96
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

Inclusion Criteria:

  • Painful osteoarthritis
  • Hydarthrosis (synovial effusion)

Exclusion Criteria:

  • large effusion
  • severe pathologies
  • anti-osteoarthritic treatments
  Contacts and Locations
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): NCT00440661


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

Responsible Party: Patrick Darses, Negma-Lerads
ClinicalTrials.gov Identifier: NCT00440661     History of Changes
Other Study ID Numbers: HEC/ART06572N
109196
First Submitted: February 26, 2007
First Posted: February 27, 2007
Last Update Posted: March 4, 2010
Last Verified: October 2007

Keywords provided by Laboratoires NEGMA:
Osteoarthritis, IL-1

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