Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis
NCT ID: NCT04627038
Last Updated: 2023-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
202 participants
INTERVENTIONAL
2020-11-12
2021-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3556050 600 mg
Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
LY3556050
LY3556050 Given orally
Placebo
Participants received placebo BID every 12 hours for up to 8 weeks.
Placebo
Placebo Given orally
Interventions
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LY3556050
LY3556050 Given orally
Placebo
Placebo Given orally
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Simon Williamson Clinic
Birmingham, Alabama, United States
Synexus- Chandler
Chandler, Arizona, United States
Synexus Clinical Research - Glendale
Glendale, Arizona, United States
Alliance for Multispecialty Research - Clinical Research Consortium
Tempe, Arizona, United States
Irvine Clinical Research
Irvine, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Suncoast Research Group
Miami, Florida, United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Synexus Clinical Research US, Inc - Orlando
Orlando, Florida, United States
Synexus Clinical Research - St. Petersburg
Pinellas Park, Florida, United States
Martin E. Hale M.D., P.A.
Plantation, Florida, United States
Synexus Clinical Research US, Inc.
The Villages, Florida, United States
Synexus Clinical Research
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Boston Clinical Trials
Boston, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
PharmQuest
Greensboro, North Carolina, United States
Synexus - Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
META Medical Research Institute
Dayton, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Cedar Health Research
Dallas, Texas, United States
Synexus - US
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis
Other Identifiers
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H0P-MC-OA03
Identifier Type: OTHER
Identifier Source: secondary_id
17593
Identifier Type: -
Identifier Source: org_study_id
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