Osteoarthritis
Conditions
Keywords
diacerein, osteoarthritis, hand
Brief summary
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.
Interventions
DRUGdiacerein
Diacerein 50mg bid
DRUGplacebo
placebo
Sponsors
Myungmoon Pharm. Co.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| AUSCAN stiffness score at 4 week point | 12wks |
| AUSCAN pain score at 12 week point | 12wk |
Countries
South Korea
Outcome results
None listed