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New treatment option for Knee Osteoarthritis
Official title Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
ClinicalTrials.gov ID: NCT04318041
What this study is testing
What is Artrodar?
Artrodar is an investigational medicine, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65
You may be able to join if
- 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)
You likely can't join if
- 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.)...
- Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein)...
- 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)
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bangkoknoi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkoknoi, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.