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.

Simon Williamson Clinic, Birmingham, Alabama

Status

Completed

Address

Simon Williamson Clinic

Birmingham, Alabama, 35211

Synexus Clinical Research - Glendale, Glendale, Arizona

Status

Completed

Address

Synexus Clinical Research - Glendale

Glendale, Arizona, 85306

Central Phoenix Medical Clinic, Phoenix, Arizona

Status

Recruiting

Address

Central Phoenix Medical Clinic

Phoenix, Arizona, 85020

Arizona Research Center, Phoenix, Arizona

Status

Recruiting

Address

Arizona Research Center

Phoenix, Arizona, 85053

Tempe, Arizona

Status

Completed

Address

Alliance for Multispecialty Research, LLC

Tempe, Arizona, 85281

Irvine Clinical Research, Irvine, California

Status

Completed

Address

Irvine Clinical Research

Irvine, California, 92614

Artemis Institute for Clinical Research, Riverside, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

Riverside, California, 92503

Artemis Institute for Clinical Research, San Diego, California

Status

Recruiting

Address

Artemis Institute for Clinical Research

San Diego, California, 92103

CMR of Greater New Haven, LLC, Hamden, Connecticut

Status

Recruiting

Address

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517

VIN-Julie Schwartzbard, Aventura, Florida

Status

Completed

Address

VIN-Julie Schwartzbard

Aventura, Florida, 33180

DeLand, Florida

Status

Recruiting

Address

Accel Research Sites- Clinical Research Unit

DeLand, Florida, 32720

Jacksonville, Florida

Status

Completed

Address

Encore Research Group- Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216

Suncoast Research Group, Miami, Florida

Status

Recruiting

Address

Suncoast Research Group

Miami, Florida, 33135

Miami, Florida

Status

Recruiting

Address

University of Miami Don Suffer Clinical Research Building

Miami, Florida, 33136

New Horizon Research Center, Miami, Florida

Status

Recruiting

Address

New Horizon Research Center

Miami, Florida, 33165

Renstar Medical Research, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research

Ocala, Florida, 34470

Synexus Clinical Research US, Inc., Orlando, Florida

Status

Recruiting

Address

Synexus Clinical Research US, Inc.

Orlando, Florida, 32806

Pinellas Park, Florida

Status

Recruiting

Address

Synexus Clinical Research - St. Petersburg

Pinellas Park, Florida, 33781

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

Status

Completed

Address

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

Plantation, Florida, 33317

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

Status

Completed

Address

Synexus Clinical Research US, Inc.

The Villages, Florida, 32162

North Georgia Clinical Research, Woodstock, Georgia

Status

Recruiting

Address

North Georgia Clinical Research

Woodstock, Georgia, 30189

Rocky Mountain Clinical Research, Idaho Falls, Idaho

Status

Recruiting

Address

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404

Synexus Clinical Research, Chicago, Illinois

Status

Completed

Address

Synexus Clinical Research

Chicago, Illinois, 60602

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Topeka, Kansas

Status

Completed

Address

Cotton O'Neil Clinical Research Center - Central Office

Topeka, Kansas, 66606

Boston Clinical Trials, Boston, Massachusetts

Status

Recruiting

Address

Boston Clinical Trials

Boston, Massachusetts, 02131

ActivMed Practices and Research, Methuen, Massachusetts

Status

Recruiting

Address

ActivMed Practices and Research

Methuen, Massachusetts, 01844

MedVadis Research Corporation, Waltham, Massachusetts

Status

Recruiting

Address

MedVadis Research Corporation

Waltham, Massachusetts, 02451

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

Status

Recruiting

Address

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706

StudyMetrix Research, Saint Peters, Missouri

Status

Recruiting

Address

StudyMetrix Research

Saint Peters, Missouri, 63303

Clinvest Research LLC, Springfield, Missouri

Status

Recruiting

Address

Clinvest Research LLC

Springfield, Missouri, 65807

Synexus Clinical Research US, Inc., Omaha, Nebraska

Status

Completed

Address

Synexus Clinical Research US, Inc.

Omaha, Nebraska, 68144

PharmQuest, Greensboro, North Carolina

Status

Completed

Address

PharmQuest

Greensboro, North Carolina, 27408

Lillestol Research, Fargo, North Dakota

Status

Recruiting

Address

Lillestol Research

Fargo, North Dakota, 58104

Synexus - Cincinnati, Cincinnati, Ohio

Status

Completed

Address

Synexus - Cincinnati

Cincinnati, Ohio, 45236

Aventiv Research Inc, Columbus, Ohio

Status

Completed

Address

Aventiv Research Inc

Columbus, Ohio, 43213

META Medical Research Institute, Dayton, Ohio

Status

Recruiting

Address

META Medical Research Institute

Dayton, Ohio, 45432

Altoona center for clinical research, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona center for clinical research

Duncansville, Pennsylvania, 16635

Clinical Research Center of Reading,LLC, Wyomissing, Pennsylvania

Status

Completed

Address

Clinical Research Center of Reading,LLC

Wyomissing, Pennsylvania, 19610

Coastal Carolina Research Center, North Charleston, South Carolina

Status

Completed

Address

Coastal Carolina Research Center

North Charleston, South Carolina, 29405

FutureSearch Trials of Neurology, Austin, Texas

Status

Recruiting

Address

FutureSearch Trials of Neurology

Austin, Texas, 78731

Synexus, Dallas, Texas

Status

Completed

Address

Synexus

Dallas, Texas, 75234

Cedar Health Research, Dallas, Texas

Status

Completed

Address

Cedar Health Research

Dallas, Texas, 75251

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

Status

Recruiting

Address

Synexus Clinical Research US, Inc.

San Antonio, Texas, 78229

SYNEXUS, Murray, Utah

Status

Completed

Address

SYNEXUS

Murray, Utah, 84123

Northwest Clinical Research Center, Bellevue, Washington

Status

Recruiting

Address

Northwest Clinical Research Center

Bellevue, Washington, 98007

Rainier Clinical Research Center, Renton, Washington

Status

Recruiting

Address

Rainier Clinical Research Center

Renton, Washington, 98057

International Sites

Ponce Medical School Foundation Inc., Ponce, Puerto Rico

Status

Recruiting

Address

Ponce Medical School Foundation Inc.

Ponce, , 00716

Latin Clinical Trial Center, San Juan, Puerto Rico

Status

Recruiting

Address

Latin Clinical Trial Center

San Juan, , 00909