Title

Effect of Diacerein on Hand Osteoarthritis
Phase IV Study of Diacerein in Human Hand Osteoarthritis
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    diacerein ...
  • Study Participants

    86
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.
Study Started
Jun 30
2008
Primary Completion
Oct 31
2009
Study Completion
Dec 31
2009
Last Update
Dec 03
2010
Estimate

Drug diacerein

Diacerein 50mg bid

  • Other names: Atrodar 50mg bid

Drug placebo

placebo

1 Experimental

Diacerein 50mg bid

2 Placebo Comparator

placebo 50mg bid

Criteria

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
No Results Posted