Phase 3 Osteoarthritis Trial, Recruiting
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:
- People who are willing to take part and sign a written consent form agreeing to participate.
- People who have previously been diagnosed with osteoarthritis of the knee or hip, based on recognised medical criteria.
- People currently experiencing a flare-up of pain in the affected joint that has lasted no longer than 3 weeks.
- People who rate their pain as moderate to severe (a score of 40 mm or more on a standard pain scale).
- Women who could become pregnant must agree to use at least one approved form of contraception during the study — options include barrier methods (such as condoms or diaphragms), hormonal methods (such as the pill, injections, implants, or patches), or an intrauterine device (IUD or IUS). Women who have been through menopause, or who have had a hysterectomy, removal of both fallopian tubes, or removal of both ovaries, are not required to meet this condition.
- Male participants must agree to use a condom as contraception during the study.
- People for whom the lead doctor determines that the study treatment is appropriate and likely to be of benefit.
Who may not be able to join:
- People who have a known allergy or intolerance to the study treatment or any of its ingredients.
- People who are currently in another clinical trial involving an experimental treatment, or who have been in one within the last two weeks.
- People whose connection to the research centre or the study sponsor could affect the reliability of the results, or people considered to be in a vulnerable situation (confirm with trial site).
- People with medical conditions that the lead doctor determines would make outpatient participation unsafe or unsuitable.
- People with a history of serious, advanced, or rapidly progressing illness of any kind that could affect how the study results are measured or create additional health risks.
- People for whom the study treatment is medically unsuitable.
- People with a history of allergic reactions to anti-inflammatory medications (NSAIDs), paracetamol (Acetaminophen), or any ingredient in the study treatment.
- People with significant gut or bowel conditions, such as stomach ulcers, Crohn's disease, ulcerative colitis, or a history of gastrointestinal bleeding.
- People who have taken opioid pain medication within the last five days.
- People who have previously tried COX-2 inhibitor medications (a type of anti-inflammatory) without success.
- People with long-term pain conditions unrelated to knee or hip osteoarthritis, such as fibromyalgia, cancer spread to the bones, or Paget's disease.
- People with a history of alcohol or drug misuse within the past year.
- People who have taken anti-inflammatory medications (NSAIDs or COX-2 inhibitors) in the 72 hours before signing the consent form — except for low-dose aspirin taken for heart protection.
- People who have had arthroscopy (keyhole joint surgery), joint fluid injections, or steroid injections into the affected joint within the last three months.
- People who have had surgery on the affected joint within the last six months.
- People who have experienced a significant injury to the affected joint within the last three weeks.
- People with a history of chronic liver failure.
- People with a history of acute or severe kidney failure (where kidney filtration is below a certain level).
- People with significant blood clotting disorders (such as Von Willebrand disease, haemophilia, or vitamin K deficiency), or people currently taking blood-thinning medications.
- People with cancer (other than a type of skin cancer called basal cell carcinoma), or people with serious illnesses where the doctor considers life expectancy to be less than one year, including severe mental illness.
- People showing symptoms that may suggest an active COVID-19 infection (such as fever, cough, or difficulty breathing), or people who have been in close contact with a suspected or confirmed COVID-19 case within the last 14 days.
- People who are pregnant, breastfeeding, planning to become pregnant during the study, or who have a positive pregnancy test.
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.
Contact this trial
Principal Investigator: Isabel E Rucker-Joerg, MD, Clinical Research Institute S.C.
Phone: 5254883785
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
Where this trial is recruiting
Primary endpoints
Comparison of the proportion of patients in each treatment group who, based on the baseline assessment, achieved a response according to the OMERACT-OARSI criteria at Weeks 1, 2, 4, and 6 of follow-up.; Number of participants Number of participants reporting treatment-related adverse events, as recorded in the patient diary.treatment-related adverse events through the patient's diary record.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.