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NCT05986292PHASE2Recruiting

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

Eli Lilly and Company

Start Date

1/30/2020

Completion Date

4/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * have a visual analog scale (VAS) pain value \>40 and \<95 at screening and prerandomization screening. * have a history of daily pain for at least 12 weeks based on participant report or medical 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 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, except rescue medication for the duration of the study 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 fibromyalgia * have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association) * have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental 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 2 years prior to screening.

Interventions

DRUG

LY3016859 ISA

DRUG

LY3556050 ISA

DRUG

LY3526318 ISA

DRUG

LY3857210 ISA

DRUG

Placebo Oral

DRUG

Placebo

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Conditions

Osteoarthritis, KneeDiabetic Neuropathic PainChronic Low-back Pain

Locations

Central Research Associates

Birmingham, Alabama 35205

United States

Simon Williamson Clinic

Birmingham, Alabama 35211

United States

Synexus Clinical Research - Glendale

Glendale, Arizona 85306

United States

Synexus Clinical Research US, Inc.

Phoenix, Arizona 85020

United States

Arizona Research Center

Phoenix, Arizona 85053

United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona 85281

United States

Irvine Clinical Research

Irvine, California 92614

United States

Desert Oasis Healthcare Medical Group

Palm Springs, California 92262

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Artemis Institute for Clinical Research

San Diego, California 92123

United States

CMR of Greater New Haven

Hamden, Connecticut 06517

United States

VIN-Julie Schwartzbard

Aventura, Florida 33180

United States

Bradenton Research Center, Inc.

Bradenton, Florida 34205

United States

Clinical Research of South Florida

Coral Gables, Florida 33134

United States

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida 32720

United States

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida 32159

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

Merritt Island Medical Research, LLC

Merritt Island, Florida 32952

United States

Flourish Research - Miami, LLC

Miami, Florida 33135

United States

University of Miami Don Suffer Clinical Research Building

Miami, Florida 33136

United States

New Horizon Research Center

Miami, Florida 33165

United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida 34652

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Synexus Clinical Research US, Inc.

Orlando, Florida 32806

United States

Synexus Clinical Research - St. Petersburg

Pinellas Park, Florida 33781

United States

Martin E. Hale M.D., P.A.

Plantation, Florida 33317

United States

Precision Clinical Research

Sunrise, Florida 33351

United States

Charter Research - Lady Lake

The Villages, Florida 32162

United States

Synexus Clinical Research US, Inc.

The Villages, Florida 32162

United States

Conquest Research

Winter Park, Florida 32789

United States

North Georgia Clinical Research

Woodstock, Georgia 30189

United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho 83404

United States

Synexus Clinical Research

Chicago, Illinois 60602

United States

Northwestern University

Chicago, Illinois 60611

United States

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas 66606

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Boston Clinical Trials

Boston, Massachusetts 02131

United States

ActivMed Practices and Research

Methuen, Massachusetts 01844

United States

Lucida Clinical Trials

New Bedford, Massachusetts 02740

United States

MedVadis Research Corporation

Waltham, Massachusetts 02451

United States

Great Lakes Research Group, Inc.

Bay City, Michigan 48706

United States

StudyMetrix Research

City of Saint Peters, Missouri 63303

United States

Clinvest Research LLC

Springfield, Missouri 65807

United States

Synexus Clinical Research US, Inc.

Omaha, Nebraska 68144

United States

Rochester Clinical Research, LLC

Rochester, New York 14609

United States

PharmQuest

Greensboro, North Carolina 27408

United States

Lillestol Research

Fargo, North Dakota 58104

United States

Synexus - Cincinnati

Cincinnati, Ohio 45236

United States

Aventiv Research Inc

Columbus, Ohio 43213

United States

META Medical Research Institute

Dayton, Ohio 45432

United States

DelRicht Research

Tulsa, Oklahoma 74133

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania 16635

United States

Clinical Research Center of Reading,LLC

Wyomissing, Pennsylvania 19610

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

Synexus

Dallas, Texas 75234

United States

Cedar Health Research

Dallas, Texas 75251

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas 76104

United States

Synexus Clinical Research US, Inc.

San Antonio, Texas 78229

United States

SYNEXUS

Murray, Utah 84123

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Rainier Clinical Research Center

Renton, Washington 98057

United States

Ponce Medical School Foundation Inc.

Ponce, 00716

Puerto Rico

Latin Clinical Trial Center

San Juan, 00909

Puerto Rico