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RECRUITING

NCT05986292

PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10000

Start Date

2020-01-30

Completion Date

2027-04

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Osteoarthritis, Knee Diabetic Neuropathic Pain Chronic Low-back Pain

Interventions

DRUG

LY3016859 ISA

Administered intravenously (IV)

DRUG

LY3556050 ISA

Administered orally

DRUG

LY3526318 ISA

Administered orally

DRUG

LY3857210 ISA

Administered orally

DRUG

Placebo Oral

Placebo administered orally

DRUG

Placebo

Placebo administered IV

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.

Locations (63)

Central Research Associates

Birmingham, Alabama, United States

Simon Williamson Clinic

Birmingham, Alabama, United States

Synexus Clinical Research - Glendale

Glendale, Arizona, United States

Synexus Clinical Research US, Inc.

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Irvine Clinical Research

Irvine, California, United States

Desert Oasis Healthcare Medical Group

Palm Springs, 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

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, United States

K2 Medical Research ORLANDO

Maitland, Florida, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Flourish Research - Miami, LLC

Miami, Florida, United States

University of Miami Don Suffer Clinical Research Building

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Synexus Clinical Research US, Inc.

Orlando, Florida, United States

Synexus Clinical Research - St. Petersburg

Pinellas Park, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Synexus Clinical Research US, Inc.

The Villages, Florida, United States

Conquest Research

Winter Park, Florida, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Synexus Clinical Research

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, United States

DelRicht Research

New Orleans, Louisiana, United States

Boston Clinical Trials

Boston, Massachusetts, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Lucida Clinical Trials

New Bedford, 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 Clinical Research US, Inc.

Omaha, Nebraska, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

PharmQuest

Greensboro, North Carolina, United States

Lillestol Research

Fargo, North Dakota, United States

Synexus - Cincinnati

Cincinnati, Ohio, United States

Aventiv Research Inc

Columbus, Ohio, United States

META Medical Research Institute

Dayton, Ohio, United States

DelRicht Research

Tulsa, Oklahoma, 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

FutureSearch Trials of Neurology

Austin, Texas, United States

Synexus

Dallas, Texas, United States

Cedar Health Research

Dallas, Texas, United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas, United States

Synexus Clinical Research US, Inc.

San Antonio, Texas, United States

SYNEXUS

Murray, Utah, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)