NCT00445276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

Enrollment Period

10 months

First QC Date

March 6, 2007

Last Update Submit

March 3, 2010

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisKneeDiacereinPainful osteoarthritisClinical trial

Outcome Measures

Primary Outcomes (1)

  • VAS on pain movement, WOMAC A 1.1 section

Secondary Outcomes (5)

  • WOMAC : total, pain, physical function

  • Paracetamol consumption

  • Global assessment of the patient

  • Responder patients with OMERACT-OARSI criteria

  • Tolerance

Interventions

DiacereinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Painful primary osteoarthritis (VAS ≥ 40 mm)
  • Radiologically proven (Kellgren \& Lawrence grade I to III)
  • Requiring the prescription of a symptomatic treatment of pain

You may not qualify if:

  • Severe associated diseases
  • Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
  • Other osteoarticular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Trousseau

Tours, 37044, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

diacerein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jean - Pierre Valat

    Unafilliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

November 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

FR(1)