Phase 2 Osteoarthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given their written consent to take part after being fully informed about the trial.
• Adults between 40 and 75 years of age at the time of screening.
• People diagnosed with knee osteoarthritis according to recognised medical criteria, with symptoms lasting more than 3 months that require medication, AND who have knee pain and bone spurs visible on X-ray, AND who also have at least one of the following: are aged 50 or older, have morning stiffness lasting less than 30 minutes, or have a crackling or grating sensation when moving the knee.
• People whose knee X-ray shows a moderate level of osteoarthritis severity (classified as Kellgren-Lawrence grade II or III).
• People whose knee pain during activity in the past 24 hours rates at least 50 out of 100 on a standard pain scale, measured at both screening and the start of the trial.
• Women who are either surgically sterilised or postmenopausal (defined as 12 months without a natural period; for women under 50, a specific hormone level is also required — confirm with trial site), are not pregnant (confirmed by a blood test), and are not breastfeeding.

Who may not be able to join:

• People with a Body Mass Index (BMI) of 35.0 or higher at screening.
• People who have developed a significant new illness within 4 weeks before or during the screening period, as determined by the trial doctor.
• People who have arthritis affecting joints other than the knee.
• People who have any other joint disease apart from knee osteoarthritis, such as rheumatoid arthritis, gout, or other related conditions (a full list can be confirmed with the trial site).
• People who have had surgery on the knee or any other joint in the past.
• People who have had steroid injections into the affected knee within the past 3 months, short-acting hyaluronic acid injections within the past 3 months, or long-acting hyaluronic acid injections within the past 6 months.
• People who have taken pain relief or symptom management treatments for the knee within 4 weeks before the trial starts, including opioid or non-opioid pain medicines, anti-inflammatory drugs, certain skin creams, physical therapy, herbal remedies, glucosamine, or chondroitin.
• People expected to need surgery during the trial period that could affect their ability to complete the study.
• People who have nerve-related (neuropathic) pain or who have taken medications commonly used for nerve pain within 4 weeks before screening.
• People who have had a heart attack, unstable chest pain (angina), stroke, mini-stroke, or a serious blood clot in a vein within the past 3 months.
• People who have significant untreated or unstable conditions affecting the liver, kidneys, nervous system, immune system, lungs, hormones, blood, heart, mental health, or cancer, or any other condition the trial doctor considers unsuitable.
• Men who have a history of low testosterone (hypogonadism), certain known causes of low testosterone such as prostate cancer treatment, infertility, or specific genetic conditions (Klinefelter syndrome or Kallmann syndrome).
• People who have used medications that affect reproductive hormone levels (such as anabolic steroids, androgens, anti-oestrogens, glucocorticoids, or opiates) within the past 6 months.
• People who have had an organ transplant.
• People with significant liver problems (based on specific blood test results) or reduced kidney function (confirm thresholds with trial site).
• People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis at screening.
• People who have had a malignant (cancerous) tumour in the past 5 years, with some exceptions for certain fully treated skin cancers or thyroid cancer (confirm with trial site).
• People who have taken systemic (whole-body) steroids for 7 or more consecutive days within the past 3 months.
• People who have taken immune-suppressing drugs, including methotrexate, within the past 3 months.
• People currently taking certain specific medications known as BCRP substrates (such as rosuvastatin or sulfasalazine), unless switched to an alternative in the same drug class before joining.
• People with a history of alcohol or drug misuse within the past 2 years, or who test positive for substance misuse at screening (with some exceptions for prescribed medications — confirm with trial site).
• People who have taken part in another clinical trial and received an experimental treatment within the past 6 months.
• People with a known allergy or sensitivity to any ingredient in the trial medication.
• People with lactose intolerance.
• People who are unwilling to use medically accepted contraception throughout the trial and for 90 days after the last dose (accepted methods include hormonal contraceptives, intrauterine devices, or surgical sterilisation — confirm with trial site).
• People who are unwilling to avoid donating sperm or eggs during the trial and for 90 days after the last dose.
• People considered unsuitable for any other reason based on lab results or the trial doctor's assessment.

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