Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

March 3, 2010 updated by: Laboratoires NEGMA

Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • CHU Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
VAS on pain movement, WOMAC A 1.1 section

Secondary Outcome Measures

Outcome Measure
Tolerance
Paracetamol consumption
WOMAC : total, pain, physical function
Global assessment of the patient
Responder patients with OMERACT-OARSI criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires NEGMA

Investigators

  • Principal Investigator: Jean - Pierre Valat, Unafilliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

September 1, 2006

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 6, 2007

First Posted (ESTIMATE)

March 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2010

Last Update Submitted That Met QC Criteria

March 3, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEC / ART 05 566 N
  • AFSSAPS:050984
  • CCPPRB:2005-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Diacerein

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe