Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Who is this study for? Patients with knee osteoarthritis
What treatments are being studied? Artrodar
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study evaluates the structure-modifying effect of Diacerein (Artrodar ®) in knee osteoarthritic (OA) patients by measuring total cartilage volume from magnetic resonance imaging (MRI) of the knee. Half of participants will receive Diacerein (Artrodar ®), while the other half will receive a placebo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:
• Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
• Grade II-III OA severity that classified by the Kellgren-Lawrence classification
• Varus malalignment ≤ 15°
• Body mass index (BMI) ≤ 30 kg/m2
• Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
• Evidence of adequate contraceptive methods in women of childbearing age
Locations
Other Locations
Thailand
Siriraj Hospital
RECRUITING
Bangkoknoi
Contact Information
Primary
Juree Patarasuwankul
juree.p@trbchemedica.co.th
+66 (0)2 264 20 10
Backup
Waraporn Sanguanworapong
waraporn.s@trbchemedica.co.th
+66 (0)2 2642010
Time Frame
Start Date: 2020-11-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 128
Treatments
Experimental: diacerein (Artrodar)
Placebo_comparator: placebo
Related Therapeutic Areas
Sponsors
Leads: TRB Chemedica