None listed
Conditions
Brief summary
We propose that treating patients with inflammatory knee osteoarthritis with the anti-inflammatory drug, diacerein, will reduce pain and joint damage. The aim of this study is to compare, using a multi-centre, randomised, placebo-controlled double-blind design over 24 weeks, the efficacy of diacerein (50 mg twice daily) vs. identical placebo to reduce pain and effusion-synovitis in 260 knee osteoarthritis patients with effusion-synovitis. We hypothesise that diacerein treatment will decrease knee pain and joint inflammation by more than identical placebo over 24 weeks.
Interventions
Diacerein (50 mg twice daily).
Participants will start the trial taking one capsule daily with food, containing 50 mg of diacerein, for the first 2 weeks. This will then be increased to two capsules daily with food, equating to 100 mg of diacerein, to be taken for the remainder of the 6 month trial.
Depending on the side-effect profile, it is possible for participants to remain on 50 mg/day at week 2 or for participants to reduce their dose from 100 mg/day back to 50 mg/day anytime during th
Diacerein (50 mg twice daily). Participants will start the trial taking one capsule daily with food, containing 50 mg of diacerein, for the first 2 weeks. This will then be increased to two capsules daily with food, equating to 100 mg of diacerein, to be taken for the remainder of the 6 month trial. Depending on the side-effect profile, it is possible for participants to remain on 50 mg/day at week 2 or for participants to reduce their dose from 100 mg/day back to 50 mg/day anytime during the trial. This decision will be made in consultation with the medical doctor at each site. The reason participants can remain on half the dose is that the effect of diacerein on pain improvement does not appear to be dose-responsive. For example the literature suggests that 50 mg/day has a similar efficacy compared to 100mg per day (-15.6 vs -18.3). Participant adherence will be monitored by counting the unused capsules at the week 12 and 24 visits.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 64 Years
Healthy volunteers
No
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.
Outcome results
None listed