A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
- Conditions
- Osteoarthritis, KneeDiabetic Neuropathic PainChronic Low-back Pain
- Interventions
- Drug: LY3016859 ISADrug: LY3556050 ISADrug: LY3526318 ISADrug: LY3857210 ISADrug: PlaceboDrug: Placebo Oral
- Registration Number
- NCT05986292
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3016859 Osteoarthritis ISA LY3016859 ISA Participants are randomized to receive either active LY3016859 or matching placebo LY3016859 Osteoarthritis ISA Placebo Participants are randomized to receive either active LY3016859 or matching placebo LY3016859 Diabetic Neuropathic Pain ISA LY3016859 ISA Participants are randomized to receive either active LY3016859 or matching placebo LY3016859 Diabetic Neuropathic Pain ISA Placebo Participants are randomized to receive either active LY3016859 or matching placebo LY3016859 Chronic Back Pain ISA LY3016859 ISA Participants are randomized to receive either active LY3016859 or matching placebo LY3016859 Chronic Back Pain ISA Placebo Participants are randomized to receive either active LY3016859 or matching placebo LY3556050 Osteoarthritis ISA LY3556050 ISA Participants are randomized to receive either active LY3556050 or matching placebo LY3556050 Diabetic Neuropathic Pain ISA Placebo Oral Participants are randomized to receive either active LY3556050 or matching placebo LY3526318 Osteoarthritis ISA LY3526318 ISA Participants are randomized to receive either active LY3526318 or matching placebo LY3526318 Osteoarthritis ISA Placebo Oral Participants are randomized to receive either active LY3526318 or matching placebo LY3556050 Chronic Back Pain ISA LY3556050 ISA Participants are randomized to receive either active LY3556050 or matching placebo LY3556050 Osteoarthritis ISA Placebo Oral Participants are randomized to receive either active LY3556050 or matching placebo LY3556050 Diabetic Neuropathic Pain ISA LY3556050 ISA Participants are randomized to receive either active LY3556050 or matching placebo LY3556050 Chronic Back Pain ISA Placebo Oral Participants are randomized to receive either active LY3556050 or matching placebo LY3526318 Diabetic Neuropathic Pain ISA LY3526318 ISA Participants are randomized to receive either active LY3526318 or matching placebo LY3526318 Diabetic Neuropathic Pain ISA Placebo Oral Participants are randomized to receive either active LY3526318 or matching placebo LY3526318 Chronic Back Pain ISA LY3526318 ISA Participants are randomized to receive either active LY3526318 or matching placebo LY3526318 Chronic Back Pain ISA Placebo Oral Participants are randomized to receive either active LY3526318 or matching placebo LY3857210 Osteoarthritis ISA LY3857210 ISA Participants are randomized to receive either active LY3857210 or matching placebo LY3857210 Osteoarthritis ISA Placebo Oral Participants are randomized to receive either active LY3857210 or matching placebo LY3857210 Diabetic Neuropathic Pain ISA LY3857210 ISA Participants are randomized to receive either active LY3857210 or matching placebo LY3857210 Diabetic Neuropathic Pain ISA Placebo Oral Participants are randomized to receive either active LY3857210 or matching placebo LY3857210 Chronic Back Pain ISA LY3857210 ISA Participants are randomized to receive either active LY3857210 or matching placebo LY3857210 Chronic Back Pain ISA Placebo Oral Participants are randomized to receive either active LY3857210 or matching placebo
- Primary Outcome Measures
Name Time Method Number of Participants Who Were Allocated to Each ISA Baseline, Up to Week 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Lucida Clinical Trials
🇺🇸New Bedford, Massachusetts, United States
Simon Williamson Clinic
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research - Glendale
🇺🇸Glendale, Arizona, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Alliance for Multispecialty Research, LLC
🇺🇸Tempe, Arizona, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
CMR of Greater New Haven
🇺🇸Hamden, Connecticut, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Accel Research Sites - DeLand Clinical Research Unit
🇺🇸DeLand, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
University of Miami Don Suffer Clinical Research Building
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Synexus Clinical Research US, Inc.
🇺🇸San Antonio, Texas, United States
Synexus Clinical Research - St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Martin E. Hale M.D., P.A.
🇺🇸Plantation, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Synexus Clinical Research
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Cotton O'Neil Clinical Research Center - Central Office
🇺🇸Topeka, Kansas, United States
DelRicht Research
🇺🇸Tulsa, Oklahoma, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
Synexus - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
META Medical Research Institute
🇺🇸Dayton, Ohio, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Clinical Research Center of Reading,LLC
🇺🇸Wyomissing, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Synexus
🇺🇸Dallas, Texas, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
SYNEXUS
🇺🇸Murray, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico