A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to test the safety and efficacy of study drug LY3526318 in participants with diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol (H0P-MC-CPMP) which is a protocol to accelerate the development of new treatments for chronic pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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 pain medications taken for chronic pain conditions for the duration of the study.

• Are at 18 years old or older at the time consent is signed.

• 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.

Locations
United States
Arizona
Synexus Clinical Research US, Inc.
Recruiting
Chandler
Synexus Clinical Research - Glendale
Recruiting
Glendale
Arizona Research Center
Not yet recruiting
Phoenix
Alliance for Multispecialty Research, LLC Tempe
Recruiting
Tempe
California
Artemis Institute for Clinical Research
Recruiting
Riverside
Artemis Institute for Clinical Research
Recruiting
San Diego
Connecticut
CMR of Greater New Haven
Recruiting
Hamden
Florida
VIN-Julie Schwartzbard
Recruiting
Aventura
New Horizon Research Center
Recruiting
Miami
Suncoast Research Group
Recruiting
Miami
University of Miami Don Suffer Clinical Research Building
Recruiting
Miami
Renstar Medical Research
Recruiting
Ocala
Synexus Clinical Research US, Inc - Orlando
Recruiting
Orlando
Synexus Clinical Research US, Inc.
Recruiting
Pinellas Park
Synexus Clinical Research US, Inc - Orlando
Recruiting
The Villages
Georgia
North Georgia Clinical Research
Not yet recruiting
Woodstock
Idaho
Rocky Mountain Clinical Research
Recruiting
Idaho Falls
Illinois
Northwestern University
Recruiting
Chicago
Synexus Clinical Research US, Inc.
Recruiting
Chicago
NorthShore University HealthSystem
Recruiting
Skokie
Massachusetts
Boston Clinical Trials
Recruiting
Boston
Joslin Diabetes Center
Not yet recruiting
Boston
ActivMed Practices and Research
Recruiting
Methuen
MedVadis Research Corporation
Recruiting
Waltham
Michigan
Great Lakes Research Group, Inc.
Recruiting
Bay City
Missouri
StudyMetrix Research
Recruiting
Saint Peters
Clinvest Research LLC
Recruiting
Springfield
Ohio
Synexus - Cincinnati
Recruiting
Cincinnati
META Medical Research Institute
Recruiting
Dayton
Pennsylvania
Altoona Center For Clinical Research
Recruiting
Duncansville
Texas
FutureSearch Trials
Recruiting
Austin
Cedar Health Research
Recruiting
Dallas
Synexus - US
Recruiting
San Antonio
Washington
Northwest Clinical Research Center
Recruiting
Bellevue
Rainier Clinical Research Center
Recruiting
Renton
Other Locations
Puerto Rico
Ponce Medical School Foundation Inc.
Recruiting
Ponce
Latin Clinical Trial Center
Recruiting
San Juan
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Time Frame
Start Date: January 26, 2022
Estimated Completion Date: November 24, 2022
Participants
Target number of participants: 150
Treatments
Experimental: LY3526318
Participants will be administered LY3526318 orally.
Placebo Comparator: Placebo
Participants will be administered placebo orally.
Authors
Neil Sheth, Corey G Anderson, Bruce G Rankin, Ezekiel Fink, Elysa Shaw, Ronald Brazg, William P. Jennings, Michael J Lillestol, Elizabeth A. Barranco-Santana, Gilbert Antonio Jenouri, John Douglas Hudson, Stacey Layle, Paul Nugent, Joseph Newberg, Samir Arora, Jeffrey A. Potts, Arkadiy Stolyar, Leslie J Klaff, David Gregory True, Carl D Vance, Louise A. Taber, Mark Eliot Kutner, Joseph Soufer, Julie Schwartzbard, Randall J Severance, David Lucius Oliver, Antonio Mendes, Jack Bailey Vu, Timothy R Smith, Lazaro D. Nunez, David DiBenedetto, Priyesh Mehta, Elly R Lee, Sarah Lavery, Linda Murray, Danielle Horn, Arifulla Khan, Bram Wieskopf, THOMAS SCHNITZER, William Kirby, Robert M Meyer, Martin E. Hale, Liana Katz Billings, Carlos A Pantojas, Michael J. McCartney, Osama Hamdy, Judith L. White, Robert Michael Griffin, Ronald Bragz, Alan Jan Kivitz
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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