RecruitingPhase 3NCT04318041

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


Sponsor

TRB Chemedica

Enrollment

128 participants

Start Date

Nov 22, 2020

Study Type

INTERVENTIONAL

Conditions

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. Half of participants will receive Diacerein (Artrodar ®), while the other half will receive a placebo.


Eligibility

Min Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether diacerein (brand name Artrodar), an anti-inflammatory medication, can slow the structural deterioration of knee cartilage in people with knee osteoarthritis by measuring total cartilage volume on MRI scans over 2 years. Osteoarthritis is the most common form of joint disease and currently lacks effective disease-modifying treatments. Adults aged 40 to 65 with a diagnosis of primary knee osteoarthritis of moderate severity (Kellgren-Lawrence grade II or III), a BMI of 30 or below, and adequate knee pain on walking may be eligible, while those with inflammatory joint diseases, recent joint injections, severe gastrointestinal disorders, or kidney or liver impairment are excluded. Participation involves taking one capsule daily (then two daily after a month) over 2 years, with MRI scans and regular clinical assessments to track cartilage changes and symptoms. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArtrodar

Diacerein (Artrodar): D1-D28 (1 month): Artrodar (50 mg) 1 x 1 with evening meal D29-end of study (23 months): Artrodar (50 mg) 1 x 2 with meal

DRUGPlacebos

Placebo: D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal


Locations(1)

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

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NCT04318041


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