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

NCT04318041 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artrodar

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

DRUG

Placebos

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

Sponsors & Collaborators

  • TRB Chemedica

    lead INDUSTRY

Principal Investigators

  • Nipaporn Jitsook · TRB Chemedica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-22
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Thailand

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318041 on ClinicalTrials.gov