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Completed

NCT Number: NCT00685542

Effect of Diacerein on Hand Osteoarthritis

Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages over 40 years-old
  • Conforming to the classification criteria of American College of Rheumatology*
  • More than 1 tender joints
  • Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks

Exclusion criteria

  • Pregnant or lactating women
  • Previous history of hypersensitivity to Diacerein
  • Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
  • Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
  • Patients who underwent surgery in any joints of the hands
  • AST/ALT > 2x upper normal range
  • Serum Cr > 1.4 mg/dl
  • Patients who have severe comorbidities such as severe congestive heart failure or pulmonary disease
  • Patients who took oral anticoagulants.
  • Patients who refuse to sign the consent form

Treatment and study plan

Diacerein

Drug

Diacerein 50mg bid

Other names: Atrodar 50mg bid

Placebo

Drug

placebo

Primary outcomes

  1. Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point

    Time frame: 12 weeks

Secondary outcomes

  1. AUSCAN stiffness score at 4 week point

    Time frame: 12wks

  2. AUSCAN pain score at 12 week point

    Time frame: 12wk

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Myungmoon Pharm. Co.

Registry information

Official study title

Phase IV Study of Diacerein in Human Hand Osteoarthritis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 28, 2008
Registry last updated
Dec 3, 2010

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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