Evaluating Diacerein's effect on knee osteoarthritis

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

This study is testing if a medication called Diacerein can help improve cartilage health and reduce symptoms in people with knee osteoarthritis over two years.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: TRB Chemedica (industry)
• Locations: 1 site (Bangkoknoi, Bangkok)
• Trial ID: NCT04318041 on ClinicalTrials.gov

What this trial studies

This study assesses the structural modification effects of Diacerein (Artrodar®) in patients with knee osteoarthritis by measuring total cartilage volume using MRI. Participants will be randomly assigned to receive either Diacerein or a placebo, with the treatment regimen lasting for 24 months. The study aims to determine if Diacerein can improve cartilage health and alleviate symptoms associated with knee osteoarthritis.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 65 with primary knee osteoarthritis of moderate severity and specific pain levels.

Not a fit: Patients with severe osteoarthritis in other joints or those who have recently undergone certain treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could potentially slow the progression of knee osteoarthritis and improve patients' quality of life.

How similar studies have performed: Previous studies have shown promise in using similar structural modification approaches for osteoarthritis, but the specific use of Diacerein in this context is less established.

Eligibility criteria

Inclusion Criteria:

1. Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
2. Grade II-III OA severity that classified by the Kellgren-Lawrence classification
3. Varus malalignment ≤ 15°
4. Body mass index (BMI) ≤ 30 kg/m2
5. Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
6. Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

1. Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
2. 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
3. Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
4. Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
5. Poor general health or other conditions which would make regular hospital attendance difficult
6. Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
7. Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
8. Evolving arthritis requiring surgery within the coming year;
9. Persistent diarrhoea (\> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
10. Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
11. Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
12. 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
13. Severe parenchymal organ disease
14. History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
15. Patient with diabetes mellitus (DM) who has heamoglobin A1c level \> 8%
16. Patient with hypertension who has systolic blood pressure \> 150 mmHg or diastolic Blood pressure \> 95 mmHg
17. Pregnancy or lactation
18. Participation in a drug clinical trial within the 3 months before the start of the study;
19. Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
20. Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
21. Knee size measured at lower thigh \> 50 cm

Where this trial is running

Bangkoknoi, Bangkok

• Siriraj Hospital — Bangkoknoi, Bangkok, Thailand (RECRUITING)

Study contacts

• Study coordinator: Juree Patarasuwankul

Conditions: Knee Osteoarthritis