Effect of Diacerein on Hand Osteoarthritis

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: diacerein; Drug: placebo

• Registration Number: NCT00685542
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-24
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Study Start: 2008-06
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	diacerein	Diacerein 50mg bid
2	placebo	placebo 50mg bid

Primary Outcome Measures

Name	Time	Method
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point	12 weeks

Secondary Outcome Measures

Name	Time	Method
AUSCAN stiffness score at 4 week point	12wks
AUSCAN pain score at 12 week point	12wk

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of