Effect of Diacerein on Hand Osteoarthritis

NCT00685542 | Completed Phase 4 DMC

• 1 other identifier: H-081-043-232
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

diacerein; osteoarthritis; hand

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (2)

• AUSCAN stiffness score at 4 week point

  12wks

• AUSCAN pain score at 12 week point

  12wk

Study Arms (2)

1

EXPERIMENTAL

Diacerein 50mg bid

Drug: diacerein

2

PLACEBO COMPARATOR

placebo 50mg bid

Drug: placebo

Interventions

diacerein DRUG

Diacerein 50mg bid

Also known as: Atrodar 50mg bid

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Myungmoon Pharm. Co.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.

  PMID: 23474153 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

diacerein; BID protein, human

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eun Bong Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

KR (1)