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Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip (ECHODIAH)

Primary Purpose

Hip Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

diacerein

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Diacerein, Hip osteoarthritis, Structure-modifying effect / Chondromodulating effect, Double blind study

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.
Lequesne algofunctional index of at list 3 points.
Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point.

Exclusion Criteria:

Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study.
Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.

Outcomes

Primary Outcome Measures

Joint space measurement

Secondary Outcome Measures

Requirement of hip replacement surgery after ten years

Tolerability

Full Information

NCT ID

NCT00451360

First Posted

March 22, 2007

Last Updated

July 24, 2008

Sponsor

Laboratoires NEGMA

1. Study Identification

Unique Protocol Identification Number

NCT00451360

Brief Title

Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

Acronym

ECHODIAH

Official Title

Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

March 1993 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Laboratoires NEGMA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

Keywords

Diacerein, Hip osteoarthritis, Structure-modifying effect / Chondromodulating effect, Double blind study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

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

Joint space measurement

Secondary Outcome Measure Information:

Title

Requirement of hip replacement surgery after ten years

Title

Tolerability

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis. Lequesne algofunctional index of at list 3 points. Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point. Exclusion Criteria: Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study. Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.

Overall Study Officials: