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NCT00440661 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440661
Other study ID # HEC/ART06572N
Secondary ID 109196
Status Completed
Phase Phase 4
First received February 26, 2007
Last updated March 3, 2010
Start date March 2007
Est. completion date October 2008

Study information
Verified date October 2007
Source Laboratoires NEGMA
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- Painful osteoarthritis

- Hydarthrosis (synovial effusion)

Exclusion Criteria:

- large effusion

- severe pathologies

- anti-osteoarthritic treatments

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Diacerhein

Locations
Country Name City State
Canada Rheumatologic Institut of Montreal Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires NEGMA

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Synovial concentration of IL-1
Secondary Synovial concentration of IL-6
Secondary WOMAC
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