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Exploration 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
Laboratoires NEGMA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, IL-1

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 26, 2007
Last Updated
March 3, 2010
Sponsor
Laboratoires NEGMA
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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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