Effect of Diacerein on Hand Osteoarthritis

December 2, 2010 updated by: Seoul National University Hospital

Phase IV Study of Diacerein in Human Hand Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Diacerein 50mg bid
Drug: diacerein
Diacerein 50mg bid
Other Names:
  • Atrodar 50mg bid
Placebo Comparator: 2
placebo 50mg bid
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
AUSCAN stiffness score at 4 week point
Time Frame: 12wks
12wks
AUSCAN pain score at 12 week point
Time Frame: 12wk
12wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Myungmoon Pharm. Co.

Investigators

  • Principal Investigator: Eun Bong Lee, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 24, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-081-043-232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe