Status:
RECRUITING
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Lead Sponsor:
TRB Chemedica
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief 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...
Detailed Description
Diacerein (Artrodar ®) participants take 1x1 with evening meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study). Placebo participants take 1x1 with evening ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
- Intra-articular treatment with any product (corticosteroids in the last 3 months, glycosaminoglycans, hyaluronic acid in the last 6 months, etc.), joint lavage or arthroscopic procedures within 6 months before the start of the study
- Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
- Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
- Poor general health or other conditions which would make regular hospital attendance difficult
- Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
- Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
- Evolving arthritis requiring surgery within the coming year;
- Persistent diarrhoea (\> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
- Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
- Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
- Hepatic disease (transaminases \> 2.5 x upper limit of normal values (ULN) or total bilirubin \> 2 x ULN) or history of alcoholism and liver disease
- Severe parenchymal organ disease
- History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
- Patient with diabetes mellitus (DM) who has heamoglobin A1c level \> 8%
- Patient with hypertension who has systolic blood pressure \> 150 mmHg or diastolic Blood pressure \> 95 mmHg
- Pregnancy or lactation
- Participation in a drug clinical trial within the 3 months before the start of the study;
- Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
- Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
- Knee size measured at lower thigh \> 50 cm
Key Trial Info
Start Date :
November 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04318041
Start Date
November 22 2020
End Date
December 31 2026
Last Update
November 22 2024
Active Locations (1)
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1
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700