Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT05177094
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2022-01-26
2022-10-13
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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LY3526318
Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.
LY3526318
Administered orally
Placebo
Participants received placebo orally, once daily, for 8-weeks treatment period.
Placebo
Administered orally
Interventions
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LY3526318
Administered orally
Placebo
Administered 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 pain medications taken for chronic pain conditions for the duration of the study.
* Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
* Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
* Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
* Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria
* Have surgery planned during the study for any reason, related or not 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 a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Have fibromyalgia
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a positive human immunodeficiency virus (HIV) test result at screening.
* 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.
* Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
* Have known hereditary motor, sensory or autonomic neuropathies.
* Are pregnant or breastfeeding.
18 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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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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Synexus Clinical Research US, Inc.
Chandler, Arizona, United States
Synexus Clinical Research - Glendale
Glendale, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Alliance for Multispecialty Research, LLC Tempe
Tempe, Arizona, 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
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 US, Inc.
Pinellas Park, Florida, United States
Synexus Clinical Research US, Inc - Orlando
The Villages, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Joslin Diabetes Center
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
Clinvest Research LLC
Springfield, Missouri, United States
Synexus - Cincinnati
Cincinnati, Ohio, United States
META Medical Research Institute
Dayton, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
FutureSearch Trials
Austin, Texas, 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 LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain
Other Identifiers
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H0P-MC-NP02
Identifier Type: OTHER
Identifier Source: secondary_id
17597
Identifier Type: -
Identifier Source: org_study_id