Back to resultsExploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Diacerhein
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, IL-1
Eligibility Criteria
Inclusion Criteria:
- Painful osteoarthritis
- Hydarthrosis (synovial effusion)
Exclusion Criteria:
- large effusion
- severe pathologies
- anti-osteoarthritic treatments
Sites / Locations
- Rheumatologic Institut of Montreal
Outcomes
Primary Outcome Measures
Synovial concentration of IL-1
Secondary Outcome Measures
Synovial concentration of IL-6
WOMAC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00440661
Brief Title
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
Official Title
Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires NEGMA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, IL-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diacerhein
Primary Outcome Measure Information:
Title
Synovial concentration of IL-1
Secondary Outcome Measure Information:
Title
Synovial concentration of IL-6
Title
WOMAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Painful osteoarthritis
Hydarthrosis (synovial effusion)
Exclusion Criteria:
large effusion
severe pathologies
anti-osteoarthritic treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre RAYNAULD, MD
Organizational Affiliation
Institut de Rhumatologie de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatologic Institut of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L1S6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
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