A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
CPMP
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
2 other identifiers
interventional
10,000
2 countries
64
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2020
Longer than P75 for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 20, 2026
April 1, 2026
7.2 years
August 1, 2023
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Were Allocated to Each ISA
Baseline, Up to Week 8
Study Arms (12)
LY3016859 Osteoarthritis ISA
EXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Diabetic Neuropathic Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Chronic Back Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3556050 Osteoarthritis ISA
EXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Diabetic Neuropathic Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Chronic Back Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3526318 Osteoarthritis ISA
EXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Diabetic Neuropathic Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Chronic Back Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3857210 Osteoarthritis ISA
EXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Diabetic Neuropathic Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Chronic Back Pain ISA
EXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
Interventions
Placebo administered orally
Placebo administered IV
Administered orally
Administered orally
Administered orally
Administered intravenously (IV)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
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
Related Publications (1)
Knopp KL, Downing AM, Anthony L, Chaterjee S, Price K, Sparks J. An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types. Pain Rep. 2024 Oct 16;9(6):e1203. doi: 10.1097/PR9.0000000000001203. eCollection 2024 Dec.
PMID: 39430683DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 14, 2023
Study Start
January 30, 2020
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.