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.
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 |
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 |
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.
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
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
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.
Status
Not yet recruiting
Address
Central Research Associates
Birmingham 4049979, Alabama 4829764, 35205
Status
Completed
Address
Simon Williamson Clinic
Birmingham 4049979, Alabama 4829764, 35211
Status
Completed
Address
Synexus Clinical Research - Glendale
Glendale 5295985, Arizona 5551752, 85306
Status
Recruiting
Address
Central Phoenix Medical Clinic
Phoenix 5308655, Arizona 5551752, 85020
Status
Recruiting
Address
Arizona Research Center
Phoenix 5308655, Arizona 5551752, 85053
Status
Completed
Address
Alliance for Multispecialty Research, LLC
Tempe 5317058, Arizona 5551752, 85281
Status
Completed
Address
Irvine Clinical Research
Irvine 5359777, California 5332921, 92614
Status
Not yet recruiting
Address
Desert Oasis Healthcare Medical Group
Palm Springs 5380668, California 5332921, 92262
Status
Recruiting
Address
Artemis Institute for Clinical Research
Riverside 5387877, California 5332921, 92503
Status
Recruiting
Address
Artemis Institute for Clinical Research
San Diego 5391811, California 5332921, 92103
Status
Recruiting
Address
CMR of Greater New Haven
Hamden 4835654, Connecticut 4831725, 06517
Status
Completed
Address
VIN-Julie Schwartzbard
Aventura 4146429, Florida 4155751, 33180
Status
Not yet recruiting
Address
Bradenton Research Center, Inc.
Bradenton 4148708, Florida 4155751, 34205
Status
Not yet recruiting
Address
Clinical Research of South Florida
Coral Gables 4151871, Florida 4155751, 33134
Status
Recruiting
Address
Accel Research Sites - DeLand Clinical Research Unit
DeLand 4152890, Florida 4155751, 32720
Status
Not yet recruiting
Address
K2 MEDICAL Research THE VILLAGES
Lady Lake 4161118, Florida 4155751, 32159
Status
Not yet recruiting
Address
K2 Medical Research ORLANDO
Maitland 4163220, Florida 4155751, 32751
Status
Not yet recruiting
Address
Merritt Island Medical Research, LLC
Merritt Island 4164092, Florida 4155751, 32952
Status
Recruiting
Address
Suncoast Research Group
Miami 4164138, Florida 4155751, 33135
Status
Not yet recruiting
Address
University of Miami Don Suffer Clinical Research Building
Miami 4164138, Florida 4155751, 33136
Status
Recruiting
Address
New Horizon Research Center
Miami 4164138, Florida 4155751, 33165
Status
Not yet recruiting
Address
Suncoast Clinical Research, Inc.
New Port Richey 4165869, Florida 4155751, 34652
Status
Recruiting
Address
Renstar Medical Research
Ocala 4166673, Florida 4155751, 34470
Status
Not yet recruiting
Address
Synexus Clinical Research US, Inc.
Orlando 4167147, Florida 4155751, 32806
Status
Completed
Address
Synexus Clinical Research - St. Petersburg
Pinellas Park 4168630, Florida 4155751, 33781
Status
Completed
Address
Martin E. Hale M.D., P.A.
Plantation 4168782, Florida 4155751, 33317
Status
Not yet recruiting
Address
Precision Clinical Research
Sunrise 4174402, Florida 4155751, 33351
Status
Not yet recruiting
Address
Charter Research - Lady Lake
The Villages 4175179, Florida 4155751, 32162
Status
Completed
Address
Synexus Clinical Research US, Inc.
The Villages 4175179, Florida 4155751, 32162
Status
Not yet recruiting
Address
Conquest Research
Winter Park 4178560, Florida 4155751, 32789
Status
Recruiting
Address
North Georgia Clinical Research
Woodstock 4231874, Georgia 4197000, 30189
Status
Not yet recruiting
Address
Rocky Mountain Clinical Research
Idaho Falls 5596475, Idaho 5596512, 83404
Status
Completed
Address
Synexus Clinical Research
Chicago 4887398, Illinois 4896861, 60602
Status
Recruiting
Address
Northwestern University
Chicago 4887398, Illinois 4896861, 60611
Status
Completed
Address
Cotton O'Neil Clinical Research Center - Central Office
Topeka 4280539, Kansas 4273857, 66606
Status
Not yet recruiting
Address
DelRicht Research
New Orleans 4335045, Louisiana 4331987, 70115
Status
Not yet recruiting
Address
Boston Clinical Trials
Boston 4930956, Massachusetts 6254926, 02131
Status
Completed
Address
ActivMed Practices and Research
Methuen 4943828, Massachusetts 6254926, 01844
Status
Not yet recruiting
Address
Lucida Clinical Trials
New Bedford 4945121, Massachusetts 6254926, 02740
Status
Recruiting
Address
MedVadis Research Corporation
Waltham 4954380, Massachusetts 6254926, 02451
Status
Recruiting
Address
Great Lakes Research Group, Inc.
Bay City 4985180, Michigan 5001836, 48706
Status
Recruiting
Address
StudyMetrix Research
City of Saint Peters 4407237, Missouri 4398678, 63303
Status
Recruiting
Address
Clinvest Research LLC
Springfield 4409896, Missouri 4398678, 65807
Status
Completed
Address
Synexus Clinical Research US, Inc.
Omaha 5074472, Nebraska 5073708, 68144
Status
Not yet recruiting
Address
Rochester Clinical Research, LLC
Rochester 5134086, New York 5128638, 14609
Status
Completed
Address
PharmQuest
Greensboro 4469146, North Carolina 4482348, 27408
Status
Recruiting
Address
Lillestol Research
Fargo 5059163, North Dakota 5690763, 58104
Status
Completed
Address
Synexus - Cincinnati
Cincinnati 4508722, Ohio 5165418, 45236
Status
Completed
Address
Aventiv Research Inc
Columbus 4509177, Ohio 5165418, 43213
Status
Recruiting
Address
META Medical Research Institute
Dayton 4509884, Ohio 5165418, 45432
Status
Not yet recruiting
Address
DelRicht Research
Tulsa 4553433, Oklahoma 4544379, 74133
Status
Recruiting
Address
Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927, 16635
Status
Completed
Address
Clinical Research Center of Reading,LLC
Wyomissing 5220248, Pennsylvania 6254927, 19610
Status
Completed
Address
Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040, 29405
Status
Recruiting
Address
FutureSearch Trials of Neurology
Austin 4671654, Texas 4736286, 78731
Status
Completed
Address
Synexus
Dallas 4684888, Texas 4736286, 75234
Status
Completed
Address
Cedar Health Research
Dallas 4684888, Texas 4736286, 75251
Status
Not yet recruiting
Address
Re:Cognition Health - Fort Worth
Fort Worth 4691930, Texas 4736286, 76104
Status
Completed
Address
Synexus Clinical Research US, Inc.
San Antonio 4726206, Texas 4736286, 78229
Status
Completed
Address
SYNEXUS
Murray 5778755, Utah 5549030, 84123
Status
Recruiting
Address
Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135, 98007
Status
Recruiting
Address
Rainier Clinical Research Center
Renton 5808189, Washington 5815135, 98057
Status
Recruiting
Address
Ponce Medical School Foundation Inc.
Ponce 4566880, , 00716
Status
Completed
Address
Latin Clinical Trial Center
San Juan 4568127, , 00909