Actively Recruiting
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Led by TRB Chemedica · Updated on 2024-11-22
128
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 40 and 65 years diagnosed with primary knee osteoarthritis (medial tibiofemoral compartment) according to ACR criteria
- Kellgren-Lawrence classification grade II-III osteoarthritis severity
- Varus malalignment of 15 degrees or less
- Body mass index (BMI) of 30 kg/m2 or less
- Pain on walking 15 meters measuring at least 30 mm on a 100 mm visual analogue pain score
- Women of childbearing age must use adequate contraceptive methods
You will not qualify if you...
- Severe osteoarthritis of the hip affecting knee function assessment
- Intra-articular treatments or joint procedures within the last 3 to 6 months
- Use of oral corticosteroids or symptomatic slow acting drugs for osteoarthritis within the last 3 months
- Current treatment with antidepressants, tranquilizers, antacids, or antibiotics
- Poor general health or conditions that hinder regular hospital visits
- Primary inflammatory painful knee conditions like rheumatoid arthritis or psoriatic arthropathy
- Other painful knee conditions such as Sudeck's atrophy or intra-articular neoplasm
- Arthritis requiring surgery within the next year
- Persistent diarrhea or laxative use
- Severe gastrointestinal disorders or history of such conditions
- Renal insufficiency with estimated glomerular filtration rate of 60 ml/min/1.73 m2 or less
- Liver disease or history of alcoholism with elevated liver enzymes or bilirubin
- Severe organ diseases
- History of heart attack, stroke, severe heart diseases, or use of clopidogrel
- Diabetes mellitus with hemoglobin A1c over 8%
- Hypertension with systolic blood pressure over 150 mmHg or diastolic over 95 mmHg
- Pregnancy or lactation
- Participation in another drug clinical trial within 3 months
- Known hypersensitivity to diacerein or related compounds
- Contraindications for MRI such as pacemaker, aneurysm clip, or claustrophobia
- Knee size at lower thigh greater than 50 cm
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Actively Recruiting
Research Team
J
Juree Patarasuwankul
CONTACT
W
Waraporn Sanguanworapong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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