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

NCT ID: NCT04318041

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-22
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

diacerein (Artrodar)

Group Type: EXPERIMENTAL

Artrodar

Intervention Type: DRUG

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

placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo:

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TRB Chemedica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nipaporn Jitsook

Role: STUDY_DIRECTOR

TRB Chemedica

Locations

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Juree Patarasuwankul

Role: CONTACT

juree.p@trbchemedica.co.th

+66 (0)2 264 20 10 ext. 1308

Waraporn Sanguanworapong

Role: CONTACT

waraporn.s@trbchemedica.co.th

+66 (0)2 2642010 ext. 1301

Facility Contacts

Keerati Chareancholvanich, MD.

Role: primary

66818188568

Other Identifiers

DAR-THA-19-01

Identifier Type: -

Identifier Source: org_study_id