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Effect of Diacerein on Hand Osteoarthritis

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis

Treatments

Drug: placebo
Drug: diacerein

Study type

Interventional

Funder types

Other

Identifiers

NCT00685542
H-081-043-232

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

86 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Diacerein 50mg bid
Treatment:
Drug: diacerein
2
Placebo Comparator group
Description:
placebo 50mg bid
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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