A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
- Osteoarthritis, Knee
- Diabetic Neuropathic Pain
- Chronic Low-back Pain
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 10,000
- Started
- 30 January 2020
- Main results due
- April 2027
- Study sites
- 64
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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 * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements 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 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(64)
Central Research Associates
Birmingham, Alabama, United States
Recruiting
Simon Williamson Clinic
Birmingham, Alabama, United States
Completed
Synexus Clinical Research - Glendale
Glendale, Arizona, United States
Completed
Synexus Clinical Research US, Inc.
Phoenix, Arizona, United States
Recruiting
Arizona Research Center
Phoenix, Arizona, United States
Recruiting
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Completed
Irvine Clinical Research
Irvine, California, United States
Completed
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Recruiting
Artemis Institute for Clinical Research
Riverside, California, United States
Recruiting
Artemis Institute for Clinical Research
San Diego, California, United States
Recruiting
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Recruiting
VIN-Julie Schwartzbard
Aventura, Florida, United States
Completed
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Recruiting
Clinical Research of South Florida
Coral Gables, Florida, United States
Not yet recruiting
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
Recruiting
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States
Recruiting
K2 Medical Research ORLANDO
Maitland, Florida, United States
Recruiting
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
Recruiting
Flourish Research - Miami, LLC
Miami, Florida, United States
Recruiting
University of Miami Don Suffer Clinical Research Building
Miami, Florida, United States
Not yet recruiting
New Horizon Research Center
Miami, Florida, United States
Recruiting
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Recruiting
Renstar Medical Research
Ocala, Florida, United States
Recruiting
Synexus Clinical Research US, Inc.
Orlando, Florida, United States
Not yet recruiting
Synexus Clinical Research - St. Petersburg
Pinellas Park, Florida, United States
Completed
Martin E. Hale M.D., P.A.
Plantation, Florida, United States
Completed
Precision Clinical Research
Sunrise, Florida, United States
Recruiting
Charter Research - Lady Lake
The Villages, Florida, United States
Recruiting
Synexus Clinical Research US, Inc.
The Villages, Florida, United States
Completed
Conquest Research
Winter Park, Florida, United States
Recruiting
North Georgia Clinical Research
Woodstock, Georgia, United States
Recruiting
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Not yet recruiting
Synexus Clinical Research
Chicago, Illinois, United States
Completed
Northwestern University
Chicago, Illinois, United States
Recruiting
Cotton O'Neil Clinical Research Center - Central Office
Topeka, Kansas, United States
Completed
DelRicht Research
New Orleans, Louisiana, United States
Recruiting
Boston Clinical Trials
Boston, Massachusetts, United States
Not yet recruiting
ActivMed Practices and Research
Methuen, Massachusetts, United States
Completed
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Recruiting
MedVadis Research Corporation
Waltham, Massachusetts, United States
Recruiting
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Recruiting
StudyMetrix Research
City of Saint Peters, Missouri, United States
Recruiting
Clinvest Research LLC
Springfield, Missouri, United States
Recruiting
Synexus Clinical Research US, Inc.
Omaha, Nebraska, United States
Completed
Rochester Clinical Research, LLC
Rochester, New York, United States
Recruiting
PharmQuest
Greensboro, North Carolina, United States
Completed
Lillestol Research
Fargo, North Dakota, United States
Recruiting
Synexus - Cincinnati
Cincinnati, Ohio, United States
Completed
Aventiv Research Inc
Columbus, Ohio, United States
Completed
META Medical Research Institute
Dayton, Ohio, United States
Recruiting
DelRicht Research
Tulsa, Oklahoma, United States
Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Recruiting
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States
Completed
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Completed
FutureSearch Trials of Neurology
Austin, Texas, United States
Recruiting
Synexus
Dallas, Texas, United States
Completed
Cedar Health Research
Dallas, Texas, United States
Completed
Re:Cognition Health - Fort Worth
Fort Worth, Texas, United States
Terminated
Synexus Clinical Research US, Inc.
San Antonio, Texas, United States
Completed
SYNEXUS
Murray, Utah, United States
Completed
Showing 60 of 64 sites — filter to narrow it down. 36 of the 64 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05986292. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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