Effect of Diacerein on Hand Osteoarthritis - Full Text View

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00685542

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 IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diacerein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IV Study of Diacerein in Human Hand Osteoarthritis

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 ]

Estimated Enrollment:	86
Study Start Date:	June 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Diacerein 50mg bid	Drug: diacerein Diacerein 50mg bid
2: Placebo Comparator placebo 50mg bid	Drug: placebo 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

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

Contacts

Contact: Eun Bong Lee, MD	822-2072-3944	leb7616@snu.ac.kr
Contact: Eun Young Lee, MD	822-2072-0852	elee@snu.ac.kr

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

Eun Bong Lee, MD

Seoul National University Hospital

More Information

Responsible Party:	Eun Bong Lee ( Seoul National University Hopital )
Study ID Numbers:	H-081-043-232
Study First Received:	May 24, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00685542
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

diacerein
osteoarthritis
hand

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009