Effect of Diacerein on Hand Osteoarthritis

Study Overview
=================
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.

Official Title
-----------------
Phase IV Study of Diacerein in Human Hand Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: diacerein
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diacerein 50mg bid | Drug: diacerein<br>* Diacerein 50mg bid<br>* Other names: Atrodar 50mg bid;|
| Placebo Comparator: 2<br>placebo 50mg bid | Drug: placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUSCAN stiffness score at 4 week point |  | 12wks | 
| AUSCAN pain score at 12 week point |  | 12wk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diacerein, osteoarthritis, hand