Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

NCT ID: NCT00445276

Last Updated: 2010-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diacerein

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laboratoires NEGMA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Negam-Lerads

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean - Pierre Valat

Role: PRINCIPAL_INVESTIGATOR

Unafilliated

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Trousseau

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AFSSAPS:050984

Identifier Type: -

Identifier Source: secondary_id

CCPPRB:2005-27

Identifier Type: -

Identifier Source: secondary_id

HEC / ART 05 566 N

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Duloxetine in Osteoarthritis (OA) Pain
NCT01558700 COMPLETED PHASE4