Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis

Launched by ELI LILLY AND COMPANY · Nov 9, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
• • Have a history of daily pain for at least 12 weeks based on participant report or medical history.
• • Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive).
• • Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
• • Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.
• • Have presence of index knee pain for \>12 weeks at screening.
• • Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.
• • Are men, or women able to abide by reproductive and contraceptive requirements.
• Exclusion Criteria:
• • Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
• • Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).
• • Have surgery planned during the study for any reason, related or not to the disease state under evaluation.
• • Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
• • Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• • Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
• • Have a positive human immunodeficiency virus (HIV) test result at screening.
• • Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
• • Have an intolerance to acetaminophen or paracetamol or any of its excipients.
• • Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
• • Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.
• • Have presence of surgical hardware or other foreign body in the index knee.
• • Have an unstable index joint (such as a torn anterior cruciate ligament).
• • Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.
• • Have fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.
• • Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
• • Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.
• • Have a history of infection in the index joint.
• • Have a history of arthritis due to crystals (e.g., gout, pseudogout).
• • Have pain or functional impairment due to ipsilateral hip osteoarthritis.
• • Have a history within 2 years prior to screening or current evidence of syncope, presyncope, uncontrolled vertigo, or postural dizziness, judged to be clinically significant by the investigator.
• • Have clinically significant active thyroid disease, including Hashimoto's thyroiditis.
• • Are taking metformin therapy.
• • Are pregnant or breastfeeding.
• • Have had any joint replacement such as knee of the lower extremity, such as hip, knee or ankle, in the past 6 months.