Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

• Status: Completed
• Trial end date: 1997-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires NEGMA
• Treatments: Diacetylrhein

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.