A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

In brief

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.

Key facts

Study ID

NCT05986292

Run by

Eli Lilly and Company

People needed

10000

Starts

2020-01-30

Expected to finish

2027-04-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Precision Clinical Research — Sunrise, Florida, United States (enrolling)
• MedVadis Research Corporation — Waltham, Massachusetts, United States (enrolling)
• Synexus Clinical Research US, Inc. — Phoenix, Arizona, United States (enrolling)
• Central Research Associates — Birmingham, Alabama, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Lucida Clinical Trials — New Bedford, Massachusetts, United States (enrolling)
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States (enrolling)
• Artemis Institute for Clinical Research — Riverside, California, United States (enrolling)
• Arizona Research Center — Phoenix, Arizona, United States (enrolling)
• CMR of Greater New Haven — Hamden, Connecticut, United States (enrolling)
• North Georgia Clinical Research — Woodstock, Georgia, United States (enrolling)
• Bradenton Research Center, Inc. — Bradenton, Florida, United States (enrolling)
• DelRicht Research — New Orleans, Louisiana, United States (enrolling)
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States (enrolling)
• K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States (enrolling)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (enrolling)
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (enrolling)
• Flourish Research - Miami, LLC — Miami, Florida, United States (enrolling)
• Artemis Institute for Clinical Research — San Diego, California, United States (enrolling)
• New Horizon Research Center — Miami, Florida, United States (enrolling)
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Charter Research - Lady Lake — The Villages, Florida, United States (enrolling)
• Conquest Research — Winter Park, Florida, United States (enrolling)
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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