Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients

TRB Chemedica

Status and phase

Enrolling

Phase 3

Conditions

Knee Osteoarthritis

Treatments

Drug: Artrodar

Drug: Placebos

Study type

Interventional

Funder types

Industry

Identifiers

NCT04318041

DAR-THA-19-01

Details and patient eligibility

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.

Full 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 meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study).

Enrollment

128 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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