Back to resultsSymptomatic Efficacy of Diacerein in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Diacerein
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Diacerein, Painful osteoarthritis, Clinical trial
Eligibility Criteria
Inclusion Criteria:
- Painful primary osteoarthritis (VAS ≥ 40 mm)
- Radiologically proven (Kellgren & Lawrence grade I to III)
- Requiring the prescription of a symptomatic treatment of pain
Exclusion Criteria:
- Severe associated diseases
- Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
- Other osteoarticular disease
Sites / Locations
- Chu Trousseau
Outcomes
Primary Outcome Measures
VAS on pain movement, WOMAC A 1.1 section
Secondary Outcome Measures
WOMAC : total, pain, physical function
Paracetamol consumption
Global assessment of the patient
Responder patients with OMERACT-OARSI criteria
Tolerance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00445276
Brief Title
Symptomatic Efficacy of Diacerein in Knee Osteoarthritis
Official Title
Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires NEGMA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Diacerein, Painful osteoarthritis, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diacerein
Primary Outcome Measure Information:
Title
VAS on pain movement, WOMAC A 1.1 section
Secondary Outcome Measure Information:
Title
WOMAC : total, pain, physical function
Title
Paracetamol consumption
Title
Global assessment of the patient
Title
Responder patients with OMERACT-OARSI criteria
Title
Tolerance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Painful primary osteoarthritis (VAS ≥ 40 mm)
Radiologically proven (Kellgren & Lawrence grade I to III)
Requiring the prescription of a symptomatic treatment of pain
Exclusion Criteria:
Severe associated diseases
Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
Other osteoarticular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean - Pierre Valat
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
Symptomatic Efficacy of Diacerein in Knee Osteoarthritis
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