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Completed

NCT Number: NCT00451360

Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

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

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Nord, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diacerein

Drug

Primary outcomes

  1. Joint space measurement

Secondary outcomes

  1. Requirement of hip replacement surgery after ten years

  2. Tolerability

Sponsors and collaborators

Lead sponsor

Laboratoires NEGMA

Industry

Registry information

Official study title

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

Acronym: ECHODIAH

Important dates

Study start
1993
Study completion
1997
First posted
Mar 23, 2007
Registry last updated
Jul 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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