Phase 1 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 who are willing and able to give written consent, follow study instructions, and attend all required visits
• People aged between 20 and 75 years (male or female)
• People who have had knee osteoarthritis (OA) symptoms for at least 6 months before the screening appointment, in one or both knees
• People whose knee OA has been confirmed using recognised medical criteria, including knee pain, plus at least one of: being over 50 years old, morning stiffness lasting less than 30 minutes, or a grating/cracking sensation in the knee, as well as bone spurs visible on X-ray
• People whose knee X-ray (taken within 6 months of screening) shows a specific level of joint damage, rated between Grade 1 and Grade 4 on a standard medical scale
• People with a body mass index (BMI) of 40 or below
• People who are able to walk and are generally in good health

Who may not be able to join:

• People with other conditions that could make it hard to accurately assess knee pain, such as certain joint disorders, other types of arthritis affecting the same knee, nerve-related pain, or other chronic pain conditions anywhere in the body (confirm with trial site)
• People whose knee joint is severely misaligned (more than 10 degrees), has an unstable joint, or has had a significant knee injury such as a ligament or cartilage tear within the past 12 months
• People diagnosed with conditions such as fibromyalgia, rheumatoid arthritis, gout, psoriatic arthritis, rapidly worsening osteoarthritis, or a number of other inflammatory or systemic joint conditions
• People who have significant fluid build-up in the knee that has required draining four or more times in the past year
• People who have had steroid injections or anti-inflammatory injections into the affected knee within the past 2–3 months, or certain other knee injections within the past 3 months
• People who have taken steroid tablets or injections into the muscle within the past month
• People who have taken strong opioid pain medications (not including tramadol or tapentadol) within the past 2 weeks
• People who have taken part in another clinical drug trial within the past 3 months
• People who have had a knee scope (arthroscopy) within the past 3 months, knee surgery within the past 6 months, certain regenerative procedures on the knee within the past 12 months, or who have ever had a full or partial knee replacement in the affected knee
• People who have planned surgery on the affected knee, any other surgery, or a planned hospital stay during the study period
• People with known allergies to anti-inflammatory medications (NSAIDs including celecoxib), sulfonamide drugs, certain inactive ingredients used in medications, or local anaesthetics such as lidocaine, or who have a history of severe allergic reactions
• People with a current or recent history (within the past 3 years) of cancer, with some exceptions for certain treated skin or cervical cancers (confirm with trial site)
• People with active or known ongoing infections, including HIV, hepatitis B or C, tuberculosis, or bone infections, or those who have needed antibiotic treatment recently, or who have had an infection in the affected knee within the past year
• People with significant abnormal results on blood tests or heart tracing (ECG) tests, as assessed by the study doctor
• People with poorly controlled diabetes, indicated by a specific blood sugar marker being above a set level at screening
• People who have had a heart attack, stroke, mini-stroke, heart bypass or stenting procedure, circulation problems in the legs, or moderate-to-severe heart failure in the past three years; or whose calculated 10-year heart disease risk is 10% or higher; or who are currently taking two blood-thinning medications together, long-term anticoagulant medication, or high-dose aspirin
• People with abnormal liver function shown in blood tests at screening
• People with significantly reduced kidney function shown in blood tests at screening
• People with an abnormal platelet count in blood tests at screening
• People with an abnormal white blood cell count in blood tests at screening
• People with active and uncontrolled mental health conditions such as psychosis, bipolar disorder, uncontrolled anxiety, or major depression
• People who test positive for certain substances (such as opioids, amphetamines, cocaine, benzodiazepines, or cannabis) on a drug screen, or who have a current or recent history of substance or alcohol misuse
• People with broken skin, a skin condition, or tattoos at or near the knee injection site that could interfere with the injection or with assessing the injection site
• People who are pregnant or breastfeeding; women who could become pregnant and are not using a recognised highly effective method of contraception
• People with any other significant health condition that, in the study doctor's judgement, would make participation unsafe or prevent the study from being completed properly

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