Phase 3 Osteoarthritis Trial, Recruiting

Written by an AI model from 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 aged 18 years or older
• People who have been diagnosed with hand osteoarthritis based on established medical criteria
• People who have had an average finger pain level of 4 or more out of 10 (where 10 is the worst pain) across fingers 2 to 5, over the past 30 days
• People who have never taken metformin before

Who may not be able to join:

• People who have, or have a history of, a medical condition that affects the joints, such as rheumatoid arthritis, gout, or psoriatic arthritis
• People who have psoriasis
• People with a known history of cancer, except for certain skin cancers (squamous or basal cell) that have been successfully treated
• People who have had issues with drug or alcohol misuse in the past year
• People who have a nerve compression condition, such as carpal tunnel syndrome
• People who have been diagnosed with diabetes
• People who have a widespread pain condition such as fibromyalgia
• People with a known nerve disease affecting the hands or feet (peripheral neuropathy)
• People with known allergies to the medications being tested in the trial
• People who have had gastric bypass surgery or have a condition that affects how the body absorbs nutrients
• People taking weight loss medication (such as GLP-1 medicines) or osteoporosis medication whose dose has not been stable for at least 3 months, or where a dose change is planned during the study
• People with any other condition or impairment that, in the trial team's opinion, would make participation unsuitable or difficult, such as certain psychiatric conditions
• People who have had surgery on the hand being studied within the past 12 months
• People who have previously had joint replacement, joint fusion, or surgical treatment for thumb base osteoarthritis in the hand being studied
• People who have used oral or injected corticosteroids at a dose equivalent to 7.5 mg or more of prednisolone per day within the past 3 months
• People currently being treated with denosumab (also known as Prolia or Xgeva)
• People who have taken part in another experimental drug or device study within the past 3 months
• People who have received any injection into a joint of the hand being studied within the past 3 months
• People who are currently using opioid pain medicines (prescription or otherwise)
• People who are planning to start another treatment for hand osteoarthritis during the study period
• People who have a CT scan with iodine contrast dye planned during the study period
• People who have surgery planned on the arm or hand being studied during the study period
• People who have any surgery planned during the study period that would require stopping metformin, such as surgery under general anaesthetic
• People who are currently pregnant
• People who are planning to become pregnant during the study period, or within 3 months after the end of treatment (for women) or 6 months after the end of treatment (for men)
• Women who are able to become pregnant and are not using adequate contraception during the study and for 3 months after treatment ends — adequate methods include an intrauterine device (coil), hormonal contraception (such as pills, implant, patch, ring, or injections), or abstinence from sex (confirm with trial site)
• Men who are not using adequate contraception during the study and for 6 months after treatment ends — adequate methods include condoms or abstinence from sex (confirm with trial site)
• People who are currently breastfeeding
• People whose blood test shows a positive anti-CCP result above a certain level, which may suggest a different type of arthritis (confirm with trial site)
• People whose kidney function is below a certain level, based on a blood test result (confirm with trial site)
• People with low vitamin B12 levels based on a blood test (confirm with trial site)
• People whose blood sugar control measure (HbA1c) is at or above a level that may suggest diabetes or pre-diabetes, based on a blood test (confirm with trial site)

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