A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Last updated: January 20, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Pain

Pain

Pain (Pediatric)

Treatment

LY3526318 ISA

LY3857210 ISA

Placebo

Clinical Study ID

NCT05986292
17511
H0P-MC-CPMP
  • Ages > 18
  • All Genders

Study Summary

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • have a visual analog scale (VAS) pain value >40 and <95 at screening andprerandomization screening.

  • have a history of daily pain for at least 12 weeks based on participant report ormedical history

  • have a value of ≤30 on the pain catastrophizing scale

  • have a body mass index <40 kilogram/square meter (kg/m²) (inclusive)

  • are willing to maintain a consistent regimen of any ongoing nonpharmacologicpain-relieving therapies (for example, physical therapy) and will not start any newnonpharmacologic pain-relieving therapies during study participation.

  • are willing to discontinue all medications taken for chronic pain conditions, exceptrescue medication for the duration of the study

Exclusion

Exclusion Criteria:

  • have second- or third-degree atrioventricular (AV) heart block or AV dissociation orhistory of ventricular tachycardia

  • have had a procedure within the past 6 months intended to produce permanent sensoryloss in the target area of interest (for example, ablation techniques)

  • have surgery planned during the study for any reason, related or not to the diseasestate under evaluation.

  • have, in the judgment of the investigator, an acute, serious, or unstable medicalcondition or a history or presence of any other medical illness that would precludestudy participation.

  • have had cancer within 2 years of baseline, except for cutaneous basal cell orsquamous cell carcinoma resolved by excision.

  • have fibromyalgia

  • have substance use disorder as defined by the Diagnostic and Statistical Manual ofMental Disorders (5th edition; DSM-5; American Psychiatric Association)

  • have any clinically important abnormality at screening, as determined byinvestigator, in physical or neurological examination, vital signs,electrocardiogram (ECG), or clinical laboratory test results that could bedetrimental to the participant or could compromise the study.

  • have a positive human immunodeficiency virus (HIV) test result at screening

  • have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2years prior to screening.

Study Design

Total Participants: 10000
Treatment Group(s): 6
Primary Treatment: LY3526318 ISA
Phase: 2
Study Start date:
January 30, 2020
Estimated Completion Date:
April 30, 2027

Study Description

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Connect with a study center

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Simon Williamson Clinic

    Birmingham, Alabama 35211
    United States

    Completed

  • Synexus Clinical Research - Glendale

    Glendale, Arizona 85306
    United States

    Completed

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Central Phoenix Medical Clinic

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona 85281
    United States

    Completed

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Completed

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    Riverside, California 92503
    United States

    Active - Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Active - Recruiting

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • VIN-Julie Schwartzbard

    Aventura, Florida 33180
    United States

    Completed

  • Clinical Research of South Florida

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Accel Research Sites- Clinical Research Unit

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Encore Research Group- Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Active - Recruiting

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida 33136
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Synexus Clinical Research - St. Petersburg

    Pinellas Park, Florida 33781
    United States

    Completed

  • Martin E. Hale M.D., P.A.

    Plantation, Florida 33317
    United States

    Completed

  • Synexus Clinical Research US, Inc.

    The Villages, Florida 32162
    United States

    Completed

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Active - Recruiting

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Physical Medicine and Rehabilitation

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Synexus Clinical Research

    Chicago, Illinois 60602
    United States

    Completed

  • Diabetes Research

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center - Central Office

    Topeka, Kansas 66606
    United States

    Completed

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Completed

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • Research

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Synexus Clinical Research US, Inc.

    Omaha, Nebraska 68144
    United States

    Completed

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Completed

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina 27408
    United States

    Completed

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Synexus - Cincinnati

    Cincinnati, Ohio 45236
    United States

    Completed

  • Rapid Medical Research

    Cleveland, Ohio 44122
    United States

    Active - Recruiting

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Completed

  • META Medical Research Institute

    Dayton, Ohio 45432
    United States

    Active - Recruiting

  • DelRicht Research

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania 19610
    United States

    Completed

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Completed

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Cedar Health Research

    Dallas, Texas 75251
    United States

    Completed

  • Synexus

    Dallas, Texas 75234
    United States

    Completed

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas 78229
    United States

    Completed

  • SYNEXUS

    Murray, Utah 84123
    United States

    Completed

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Active - Recruiting

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