An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types.
Kelly L Knopp, AnnCatherine M Downing, Leslie Anthony...
https://pubmed.ncbi.nlm.nih.gov/39430683Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05986292
A Master Protocol for Randomized Placebo-Controlled Trials Evaluating Multiple Treatments for Chronic Pain Conditions Including Knee Osteoarthritis, Diabetic Neuropathic Pain, and Low Back Pain
Led by Eli Lilly and Company · Updated on 2026-04-20
10000
Participants Needed
64
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.
CONDITIONS
Official Title
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have a visual analog scale (VAS) pain value greater than 40 and less than 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 0 or less on the pain catastrophizing scale
- Have a body mass index less than 40 kilogram/square meter (kg/m2) inclusive
- Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies 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 will not qualify if you...
- 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
- Have surgery planned during the study for any reason, related or not to the disease state under evaluation
- Have 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 DSM-5
- Have any clinically important abnormality at screening in physical or neurological examination, vital signs, ECG, or clinical laboratory tests
- Have a positive HIV test result at screening
- Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Trial Site Locations
Total: 64 locations
1
Central Research Associates
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Simon Williamson Clinic
Birmingham, Alabama, United States, 35211
Completed
3
Synexus Clinical Research - Glendale
Glendale, Arizona, United States, 85306
Completed
4
Synexus Clinical Research US, Inc.
Phoenix, Arizona, United States, 85020
Actively Recruiting
5
Arizona Research Center
Phoenix, Arizona, United States, 85053
Actively Recruiting
6
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States, 85281
Completed
7
Irvine Clinical Research
Irvine, California, United States, 92614
Completed
8
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
Actively Recruiting
9
Artemis Institute for Clinical Research
Riverside, California, United States, 92503
Actively Recruiting
10
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
11
CMR of Greater New Haven
Hamden, Connecticut, United States, 06517
Actively Recruiting
12
VIN-Julie Schwartzbard
Aventura, Florida, United States, 33180
Completed
13
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Actively Recruiting
14
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Not Yet Recruiting
15
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States, 32720
Actively Recruiting
16
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States, 32159
Actively Recruiting
17
K2 Medical Research ORLANDO
Maitland, Florida, United States, 32751
Actively Recruiting
18
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States, 32952
Actively Recruiting
19
Flourish Research - Miami, LLC
Miami, Florida, United States, 33135
Actively Recruiting
20
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States, 33136
Not Yet Recruiting
21
New Horizon Research Center
Miami, Florida, United States, 33165
Actively Recruiting
22
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Actively Recruiting
23
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
24
Synexus Clinical Research US, Inc.
Orlando, Florida, United States, 32806
Not Yet Recruiting
25
Synexus Clinical Research - St. Petersburg
Pinellas Park, Florida, United States, 33781
Completed
26
Martin E. Hale M.D., P.A.
Plantation, Florida, United States, 33317
Completed
27
Precision Clinical Research
Sunrise, Florida, United States, 33351
Actively Recruiting
28
Charter Research - Lady Lake
The Villages, Florida, United States, 32162
Actively Recruiting
29
Synexus Clinical Research US, Inc.
The Villages, Florida, United States, 32162
Completed
30
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
31
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
Actively Recruiting
32
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
33
Synexus Clinical Research
Chicago, Illinois, United States, 60602
Completed
34
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
35
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, United States, 66606
Completed
36
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
37
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Not Yet Recruiting
38
ActivMed Practices and Research
Methuen, Massachusetts, United States, 01844
Completed
39
Lucida Clinical Trials
New Bedford, Massachusetts, United States, 02740
Actively Recruiting
40
MedVadis Research Corporation
Waltham, Massachusetts, United States, 02451
Actively Recruiting
41
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
Actively Recruiting
42
StudyMetrix Research
City of Saint Peters, Missouri, United States, 63303
Actively Recruiting
43
Clinvest Research LLC
Springfield, Missouri, United States, 65807
Actively Recruiting
44
Synexus Clinical Research US, Inc.
Omaha, Nebraska, United States, 68144
Completed
45
Rochester Clinical Research, LLC
Rochester, New York, United States, 14609
Actively Recruiting
46
PharmQuest
Greensboro, North Carolina, United States, 27408
Completed
47
Lillestol Research
Fargo, North Dakota, United States, 58104
Actively Recruiting
48
Synexus - Cincinnati
Cincinnati, Ohio, United States, 45236
Completed
49
Aventiv Research Inc
Columbus, Ohio, United States, 43213
Completed
50
META Medical Research Institute
Dayton, Ohio, United States, 45432
Actively Recruiting
51
DelRicht Research
Tulsa, Oklahoma, United States, 74133
Actively Recruiting
52
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
53
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States, 19610
Completed
54
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Completed
55
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Actively Recruiting
56
Synexus
Dallas, Texas, United States, 75234
Completed
57
Cedar Health Research
Dallas, Texas, United States, 75251
Completed
58
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
59
Synexus Clinical Research US, Inc.
San Antonio, Texas, United States, 78229
Completed
60
SYNEXUS
Murray, Utah, United States, 84123
Completed
61
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
62
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Actively Recruiting
63
Ponce Medical School Foundation Inc.
Ponce, Puerto Rico, 00716
Actively Recruiting
64
Latin Clinical Trial Center
San Juan, Puerto Rico, 00909
Completed
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Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
12
Frequently Asked Questions
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