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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires NEGMA
ClinicalTrials.gov Identifier:
NCT00440661
First received: February 26, 2007
Last updated: March 3, 2010
Last verified: October 2007
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Painful osteoarthritis
  • Hydarthrosis (synovial effusion)

Exclusion Criteria:

  • large effusion
  • severe pathologies
  • anti-osteoarthritic treatments
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Patrick Darses, Negma-Lerads
ClinicalTrials.gov Identifier: NCT00440661     History of Changes
Other Study ID Numbers: HEC/ART06572N, 109196
Study First Received: February 26, 2007
Last Updated: March 3, 2010
Health Authority: Canada: Health Canada

Keywords provided by Laboratoires NEGMA:
Osteoarthritis, IL-1

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

ClinicalTrials.gov processed this record on August 20, 2014