DICKENS - A randomised controlled trial of diacerein to treat knee osteoarthritis with effusion-synovitis

Phase 2

Recruiting

• Conditions: Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12618001656224
• Lead Sponsor: niversity of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-08
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Males and females aged 40 to 64 years old.
2. Significant knee pain on most days (defined as a visual analogue scale (VAS) greater than or equal to 40mm).
3. Meet American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis confirmed by a rheumatologist.
4. Any knee effusion-synovitis present on MRI.
5. Participants who are screened via Telehealth must have radiographic knee osteoarthritis defined as joint space narrowing or an osteophyte present (score >=1 on the OARSI atlas).
5. Are willing to participate in the study for 6 months.

Exclusion Criteria

1. Inability to provide informed consent.
2. Contraindication to MRI scanning (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for scanner).
3. Severe knee osteoarthritis (defined as joint space narrowing (JSN) on X-ray as Grade 3 using the OARSI atlas.
4. Other forms of arthritis (e.g., rheumatoid arthritis, gout or other inflammatory arthritis).
5. Significant knee injury in the study knee within the last 6 months.
6. Arthroscopy or open surgery in the study knee in the last 12 months.
7. Receiving intra-articular therapy (e.g. corticosteroids, hyaluronic acid) in the study knee in the last 6 months.
8. Planned arthroscopy or joint replacement surgery during the study period.
9. Contraindication to diacerein use including:
a.Patients with a known tendency towards diarrhoea.
b.Patients with inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis).
c.Patients who have stomach problems whose cause is unknown.
d.Patients who are taking a diuretic medication or heart failure medication (digitalis glycoside).
e.Patients that have a current and/or history of liver disease (alanine transaminase (ALT) greater than or equal to 110 U/L) .
f.Patients with abnormal kidney function (creatinine clearance < 30 ml/min).
g.Patients with a known hypersensitivity to this sort of medication, i.e. anthraquinone derivatives (includes some laxatives (dantron, emodin, aloe emodin and some senna glycolsides), antimalarials, and antineoplastics used in the treatment of cancer (mitoxantrone, pixantrone, and the anthracyclines).
h.Patients who are having ongoing antibiotic and/or chemotherapy treatment.
i.Patients who are lactose intolerant, as the study medication contains lactose.
j.Women who are pregnant or breastfeeding.
10. Use of any investigational drug(s) and/or devices within 30 days or 5 half-lives (whichever is longer) prior to randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified