Effect of Diacerein on Hand Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00685542
• Date of registration: 24/05/2008
• Prospective Registration: Yes
• Primary sponsor: Seoul National University Hospital
• Public title: Effect of Diacerein on Hand Osteoarthritis
• Scientific title: Phase IV Study of Diacerein in Human Hand Osteoarthritis
• Date of first enrolment: June 2008
• Target sample size: 86
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00685542
• 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
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Eun Bong Lee, MD
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Drug: diacerein

Drug: placebo

Primary Outcome(s)

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

Secondary Outcome(s)

AUSCAN pain score at 12 week point [Time Frame: 12wk]

AUSCAN stiffness score at 4 week point [Time Frame: 12wks]

Secondary ID(s)

H-081-043-232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Myungmoon Pharm. Co.