Effect of Diacerein on Hand Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Myungmoon Pharm. Co.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00685542
First received: May 24, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: diacerein
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Diacerein in Human Hand Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUSCAN stiffness score at 4 week point [ Time Frame: 12wks ] [ Designated as safety issue: Yes ]
  • AUSCAN pain score at 12 week point [ Time Frame: 12wk ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Diacerein 50mg bid
Drug: diacerein
Diacerein 50mg bid
Other Name: Atrodar 50mg bid
Placebo Comparator: 2
placebo 50mg bid
Drug: placebo
placebo
Other Name: placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685542

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Myungmoon Pharm. Co.
Investigators
Principal Investigator: Eun Bong Lee, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hopital, Eun Bong Lee
ClinicalTrials.gov Identifier: NCT00685542     History of Changes
Other Study ID Numbers: H-081-043-232
Study First Received: May 24, 2008
Last Updated: December 2, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
diacerein
osteoarthritis
hand

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diacetylrhein
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014