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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05986292
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain
Additional Details

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.

Arms & Interventions

Arms

Experimental: LY3016859 Osteoarthritis ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3016859 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3016859 Chronic Back Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3556050 Osteoarthritis ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3556050 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3556050 Chronic Back Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3526318 Osteoarthritis ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3526318 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3526318 Chronic Back Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3857210 Osteoarthritis ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Experimental: LY3857210 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Experimental: LY3857210 Chronic Back Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Central Research Associates, Birmingham 4049979, Alabama 4829764

Status

Not yet recruiting

Address

Central Research Associates

Birmingham 4049979, Alabama 4829764, 35205

Simon Williamson Clinic, Birmingham 4049979, Alabama 4829764

Status

Completed

Address

Simon Williamson Clinic

Birmingham 4049979, Alabama 4829764, 35211

Synexus Clinical Research - Glendale, Glendale 5295985, Arizona 5551752

Status

Completed

Address

Synexus Clinical Research - Glendale

Glendale 5295985, Arizona 5551752, 85306

Central Phoenix Medical Clinic, Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Central Phoenix Medical Clinic

Phoenix 5308655, Arizona 5551752, 85020

Arizona Research Center, Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Arizona Research Center

Phoenix 5308655, Arizona 5551752, 85053

Tempe 5317058, Arizona 5551752

Status

Completed

Address

Alliance for Multispecialty Research, LLC

Tempe 5317058, Arizona 5551752, 85281

Irvine Clinical Research, Irvine 5359777, California 5332921

Status

Completed

Address

Irvine Clinical Research

Irvine 5359777, California 5332921, 92614

Desert Oasis Healthcare Medical Group, Palm Springs 5380668, California 5332921

Status

Not yet recruiting

Address

Desert Oasis Healthcare Medical Group

Palm Springs 5380668, California 5332921, 92262

Artemis Institute for Clinical Research, Riverside 5387877, California 5332921

Status

Recruiting

Address

Artemis Institute for Clinical Research

Riverside 5387877, California 5332921, 92503

Artemis Institute for Clinical Research, San Diego 5391811, California 5332921

Status

Recruiting

Address

Artemis Institute for Clinical Research

San Diego 5391811, California 5332921, 92103

CMR of Greater New Haven, Hamden 4835654, Connecticut 4831725

Status

Recruiting

Address

CMR of Greater New Haven

Hamden 4835654, Connecticut 4831725, 06517

VIN-Julie Schwartzbard, Aventura 4146429, Florida 4155751

Status

Completed

Address

VIN-Julie Schwartzbard

Aventura 4146429, Florida 4155751, 33180

Bradenton Research Center, Inc., Bradenton 4148708, Florida 4155751

Status

Not yet recruiting

Address

Bradenton Research Center, Inc.

Bradenton 4148708, Florida 4155751, 34205

Clinical Research of South Florida, Coral Gables 4151871, Florida 4155751

Status

Not yet recruiting

Address

Clinical Research of South Florida

Coral Gables 4151871, Florida 4155751, 33134

DeLand 4152890, Florida 4155751

Status

Recruiting

Address

Accel Research Sites - DeLand Clinical Research Unit

DeLand 4152890, Florida 4155751, 32720

K2 MEDICAL Research THE VILLAGES, Lady Lake 4161118, Florida 4155751

Status

Not yet recruiting

Address

K2 MEDICAL Research THE VILLAGES

Lady Lake 4161118, Florida 4155751, 32159

K2 Medical Research ORLANDO, Maitland 4163220, Florida 4155751

Status

Not yet recruiting

Address

K2 Medical Research ORLANDO

Maitland 4163220, Florida 4155751, 32751

Merritt Island Medical Research, LLC, Merritt Island 4164092, Florida 4155751

Status

Not yet recruiting

Address

Merritt Island Medical Research, LLC

Merritt Island 4164092, Florida 4155751, 32952

Suncoast Research Group, Miami 4164138, Florida 4155751

Status

Recruiting

Address

Suncoast Research Group

Miami 4164138, Florida 4155751, 33135

Miami 4164138, Florida 4155751

Status

Not yet recruiting

Address

University of Miami Don Suffer Clinical Research Building

Miami 4164138, Florida 4155751, 33136

New Horizon Research Center, Miami 4164138, Florida 4155751

Status

Recruiting

Address

New Horizon Research Center

Miami 4164138, Florida 4155751, 33165

Suncoast Clinical Research, Inc., New Port Richey 4165869, Florida 4155751

Status

Not yet recruiting

Address

Suncoast Clinical Research, Inc.

New Port Richey 4165869, Florida 4155751, 34652

Renstar Medical Research, Ocala 4166673, Florida 4155751

Status

Recruiting

Address

Renstar Medical Research

Ocala 4166673, Florida 4155751, 34470

Synexus Clinical Research US, Inc., Orlando 4167147, Florida 4155751

Status

Not yet recruiting

Address

Synexus Clinical Research US, Inc.

Orlando 4167147, Florida 4155751, 32806

Pinellas Park 4168630, Florida 4155751

Status

Completed

Address

Synexus Clinical Research - St. Petersburg

Pinellas Park 4168630, Florida 4155751, 33781

Martin E. Hale M.D., P.A., Plantation 4168782, Florida 4155751

Status

Completed

Address

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

Plantation 4168782, Florida 4155751, 33317

Precision Clinical Research, Sunrise 4174402, Florida 4155751

Status

Not yet recruiting

Address

Precision Clinical Research

Sunrise 4174402, Florida 4155751, 33351

Charter Research - Lady Lake, The Villages 4175179, Florida 4155751

Status

Not yet recruiting

Address

Charter Research - Lady Lake

The Villages 4175179, Florida 4155751, 32162

Synexus Clinical Research US, Inc., The Villages 4175179, Florida 4155751

Status

Completed

Address

Synexus Clinical Research US, Inc.

The Villages 4175179, Florida 4155751, 32162

Conquest Research, Winter Park 4178560, Florida 4155751

Status

Not yet recruiting

Address

Conquest Research

Winter Park 4178560, Florida 4155751, 32789

North Georgia Clinical Research, Woodstock 4231874, Georgia 4197000

Status

Recruiting

Address

North Georgia Clinical Research

Woodstock 4231874, Georgia 4197000, 30189

Rocky Mountain Clinical Research, Idaho Falls 5596475, Idaho 5596512

Status

Not yet recruiting

Address

Rocky Mountain Clinical Research

Idaho Falls 5596475, Idaho 5596512, 83404

Synexus Clinical Research, Chicago 4887398, Illinois 4896861

Status

Completed

Address

Synexus Clinical Research

Chicago 4887398, Illinois 4896861, 60602

Northwestern University, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

Northwestern University

Chicago 4887398, Illinois 4896861, 60611

Topeka 4280539, Kansas 4273857

Status

Completed

Address

Cotton O'Neil Clinical Research Center - Central Office

Topeka 4280539, Kansas 4273857, 66606

DelRicht Research, New Orleans 4335045, Louisiana 4331987

Status

Not yet recruiting

Address

DelRicht Research

New Orleans 4335045, Louisiana 4331987, 70115

Boston Clinical Trials, Boston 4930956, Massachusetts 6254926

Status

Not yet recruiting

Address

Boston Clinical Trials

Boston 4930956, Massachusetts 6254926, 02131

ActivMed Practices and Research, Methuen 4943828, Massachusetts 6254926

Status

Completed

Address

ActivMed Practices and Research

Methuen 4943828, Massachusetts 6254926, 01844

Lucida Clinical Trials, New Bedford 4945121, Massachusetts 6254926

Status

Not yet recruiting

Address

Lucida Clinical Trials

New Bedford 4945121, Massachusetts 6254926, 02740

MedVadis Research Corporation, Waltham 4954380, Massachusetts 6254926

Status

Recruiting

Address

MedVadis Research Corporation

Waltham 4954380, Massachusetts 6254926, 02451

Great Lakes Research Group, Inc., Bay City 4985180, Michigan 5001836

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City 4985180, Michigan 5001836, 48706

StudyMetrix Research, City of Saint Peters 4407237, Missouri 4398678

Status

Recruiting

Address

StudyMetrix Research

City of Saint Peters 4407237, Missouri 4398678, 63303

Clinvest Research LLC, Springfield 4409896, Missouri 4398678

Status

Recruiting

Address

Clinvest Research LLC

Springfield 4409896, Missouri 4398678, 65807

Synexus Clinical Research US, Inc., Omaha 5074472, Nebraska 5073708

Status

Completed

Address

Synexus Clinical Research US, Inc.

Omaha 5074472, Nebraska 5073708, 68144

Rochester Clinical Research, LLC, Rochester 5134086, New York 5128638

Status

Not yet recruiting

Address

Rochester Clinical Research, LLC

Rochester 5134086, New York 5128638, 14609

PharmQuest, Greensboro 4469146, North Carolina 4482348

Status

Completed

Address

PharmQuest

Greensboro 4469146, North Carolina 4482348, 27408

Lillestol Research, Fargo 5059163, North Dakota 5690763

Status

Recruiting

Address

Lillestol Research

Fargo 5059163, North Dakota 5690763, 58104

Synexus - Cincinnati, Cincinnati 4508722, Ohio 5165418

Status

Completed

Address

Synexus - Cincinnati

Cincinnati 4508722, Ohio 5165418, 45236

Aventiv Research Inc, Columbus 4509177, Ohio 5165418

Status

Completed

Address

Aventiv Research Inc

Columbus 4509177, Ohio 5165418, 43213

META Medical Research Institute, Dayton 4509884, Ohio 5165418

Status

Recruiting

Address

META Medical Research Institute

Dayton 4509884, Ohio 5165418, 45432

DelRicht Research, Tulsa 4553433, Oklahoma 4544379

Status

Not yet recruiting

Address

DelRicht Research

Tulsa 4553433, Oklahoma 4544379, 74133

Altoona Center For Clinical Research, Duncansville 5187508, Pennsylvania 6254927

Status

Recruiting

Address

Altoona Center For Clinical Research

Duncansville 5187508, Pennsylvania 6254927, 16635

Clinical Research Center of Reading,LLC, Wyomissing 5220248, Pennsylvania 6254927

Status

Completed

Address

Clinical Research Center of Reading,LLC

Wyomissing 5220248, Pennsylvania 6254927, 19610

Coastal Carolina Research Center, North Charleston 4589387, South Carolina 4597040

Status

Completed

Address

Coastal Carolina Research Center

North Charleston 4589387, South Carolina 4597040, 29405

FutureSearch Trials of Neurology, Austin 4671654, Texas 4736286

Status

Recruiting

Address

FutureSearch Trials of Neurology

Austin 4671654, Texas 4736286, 78731

Synexus, Dallas 4684888, Texas 4736286

Status

Completed

Address

Synexus

Dallas 4684888, Texas 4736286, 75234

Cedar Health Research, Dallas 4684888, Texas 4736286

Status

Completed

Address

Cedar Health Research

Dallas 4684888, Texas 4736286, 75251

Re:Cognition Health - Fort Worth, Fort Worth 4691930, Texas 4736286

Status

Not yet recruiting

Address

Re:Cognition Health - Fort Worth

Fort Worth 4691930, Texas 4736286, 76104

Synexus Clinical Research US, Inc., San Antonio 4726206, Texas 4736286

Status

Completed

Address

Synexus Clinical Research US, Inc.

San Antonio 4726206, Texas 4736286, 78229

SYNEXUS, Murray 5778755, Utah 5549030

Status

Completed

Address

SYNEXUS

Murray 5778755, Utah 5549030, 84123

Northwest Clinical Research Center, Bellevue 5786882, Washington 5815135

Status

Recruiting

Address

Northwest Clinical Research Center

Bellevue 5786882, Washington 5815135, 98007

Rainier Clinical Research Center, Renton 5808189, Washington 5815135

Status

Recruiting

Address

Rainier Clinical Research Center

Renton 5808189, Washington 5815135, 98057

International Sites

Ponce Medical School Foundation Inc., Ponce 4566880, Puerto Rico

Status

Recruiting

Address

Ponce Medical School Foundation Inc.

Ponce 4566880, , 00716

Latin Clinical Trial Center, San Juan 4568127, Puerto Rico

Status

Completed

Address

Latin Clinical Trial Center

San Juan 4568127, , 00909