Phase 3 Osteoarthritis Trial, Recruiting NCT04318041 Sponsor: TRB Chemedica Condition: Osteoarthritis
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Phase 3 Osteoarthritis Trial, Recruiting

NCT04318041
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 40 and 65 years old and have been diagnosed with primary osteoarthritis (OA) in the inner part of your knee joint
  • Your knee osteoarthritis has been rated as moderate in severity (Grade II or III on a standard medical scale)
  • The inward bowing of your knee (varus, or "bow-legged" alignment) is no more than 15 degrees
  • Your body mass index (BMI) is 30 or below (confirm with trial site if unsure how to calculate this)
  • You experience pain of at least 30 out of 100 on a pain scale when walking 15 metres
  • If you are a woman who could become pregnant, you are using a reliable form of contraception

Who may not be able to join:

  • You have hip osteoarthritis that is severe enough to affect how your knee is assessed
  • You have received any injection into the knee joint (such as steroid injections in the last 3 months, or hyaluronic acid/similar products in the last 6 months), or had a knee wash-out or keyhole procedure within the last 6 months
  • You have taken steroid tablets or certain joint supplement medicines (such as glucosamine or chondroitin) in the last 3 months
  • You are currently taking antidepressants, tranquilisers, antacids, or antibiotics
  • You have poor overall health or another condition that would make it difficult for you to attend the hospital regularly
  • Your knee pain is caused by an inflammatory condition such as rheumatoid arthritis, psoriatic arthritis, or pseudo-gout
  • Your knee pain is caused by a condition other than osteoarthritis (confirm with trial site for specific examples)
  • Your joint condition is expected to need surgery within the next year
  • You have ongoing diarrhoea (more than 3 bowel movements per day) or regularly use laxatives
  • You have serious stomach or bowel problems, or a history of them, such as stomach ulcers, ulcerative colitis, Crohn's disease, diverticulitis, or recurring pancreatitis
  • You have reduced kidney function below a certain level (confirm with trial site)
  • You have liver disease or abnormal liver test results, or a history of alcoholism affecting the liver
  • You have severe disease affecting a major organ (confirm with trial site)
  • You have had a heart attack or stroke, have been diagnosed with heart failure, or take a blood-thinning medicine called clopidogrel
  • You have diabetes and your long-term blood sugar level (HbA1c) is above 8%
  • You have high blood pressure that is not well controlled (above 150/95 mmHg)
  • You are pregnant or breastfeeding
  • You have taken part in another drug clinical trial in the last 3 months
  • You have a known allergy or sensitivity to diacerein (the study drug) or similar substances, or to paracetamol, naproxen, or omeprazole
  • You are unable to have an MRI scan — for example, because you have a pacemaker, a certain type of surgical clip, or severe claustrophobia
  • The measurement around your lower thigh (knee area) is greater than 50 cm

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nipaporn Jitsook, TRB Chemedica

Phone: +66 (0)2 264 20 10

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
TRB Chemedica
Registry
ClinicalTrials.gov
Start date
22 November 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇹🇭 Thailand

Primary endpoints

Cartilage volume measured by MRI of the affected knee.; Bone marrow lesions measured by MRI of the affected knee.; Synovitis measured by MRI of the affected knee.; Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov