RCT, Blinded, 2-Arm Efficacy Study of IP and Placebo in Patients With Chronic Pain Related to Osteoarthritis of the Knee (NCT05318521)

Usually NOT eligible if any of the following apply:

• Exclusion Criteria:
• Patients with a history of gastroduodenal perforations and/or obstructions; gastric and/or duodenal surgery; recent (≤ 6 months) active gastrointestinal (GI) ulceration; inflammatory bowel disease; GI bleeding in the past year.
• Patients with a history of congestive heart failure, coronary artery disease, renal artery stenosis or recent (within 1 year) myocardial infarction, angina, stroke, or transient ischemic attack and/or with uncontrolled hypertension.
• Patients with moderate to severe hepatic impairment (alanine aminotransferase \[ALT\] or aspartate transaminase \[AST\] concentrations \> 2.5 times the upper limit of normal).
• Patients with a medical condition (e.g., a cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine \[adrenal hyperplasia\], immunologic, dermatologic, neurologic, oncologic, or psychiatric) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.
• Patients receiving ongoing opioid therapy for their OA-related pain; or requiring ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments known to interfere with pain perception. (Note: 'stabilized' is defined as being used for at least 3 months).
• Patients who have received intra-articular injection of corticosteroids, hyaluronic acid or platelet-rich plasma in the target knee within 6 months prior to the screening visit (within 1 year for long-acting formulations); or have received opioid medication within 14 days prior to the screening visit.
• Patients who are unable to be prescribed NSAIDs or are known or suspected to have hypersensitivity to study medication or their excipients.
• Patients who have participated in investigational drug trials and took any investigational therapy within 90 days or a time of 5 half-lives prior to the study dosing.
• Patients currently pregnant, lactating, or planning to pregnant during the trial period. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods mentioned below, during dosing and for at least 4 weeks after stopping study treatment.
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.