A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Recruiting · NCT05986292 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
LY3016859 ISALY3526318 ISALY3556050 ISALY3857210 ISALY4065967 ISAPlaceboPlacebo Oral
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 24 US states.
- Central Research Associates - Birmingham, Alabama, United States
- Simon Williamson Clinic - Birmingham, Alabama, United States
- Synexus Clinical Research - Glendale - Glendale, Arizona, United States
- Synexus Clinical Research US, Inc. - 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 - Riverside, 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
- Bradenton Research Center, Inc. - Bradenton, Florida, United States
- Clinical Research of South Florida - Coral Gables, Florida, United States
- Accel Research Sites - DeLand Clinical Research Unit - DeLand, Florida, United States
- K2 MEDICAL Research THE VILLAGES - Lady Lake, Florida, United States
- K2 Medical Research ORLANDO - Maitland, Florida, United States
- Merritt Island Medical Research, LLC - Merritt Island, Florida, United States
- Flourish Research - Miami, LLC - Miami, Florida, United States
- University of Miami Don Suffer Clinical Research Building - Miami, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Suncoast Clinical Research, Inc. - New Port Richey, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Synexus Clinical Research US, Inc. - Orlando, Florida, United States
- Synexus Clinical Research - St. Petersburg - Pinellas Park, Florida, United States
- Martin E. Hale M.D., P.A. - Plantation, Florida, United States
- Precision Clinical Research - Sunrise, Florida, United States
- Charter Research - Lady Lake - The Villages, Florida, United States
- Synexus Clinical Research US, Inc. - The Villages, Florida, United States
- Conquest Research - Winter Park, 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 - New Orleans, Louisiana, United States
- Boston Clinical Trials - Boston, Massachusetts, United States
- ActivMed Practices and Research - Methuen, Massachusetts, United States
- Lucida Clinical Trials - New Bedford, Massachusetts, United States
- MedVadis Research Corporation - Waltham, Massachusetts, United States
- Great Lakes Research Group, Inc. - Bay City, Michigan, United States
- StudyMetrix Research - City of Saint Peters, Missouri, United States
- Clinvest Research LLC - Springfield, Missouri, United States
- Synexus Clinical Research US, Inc. - Omaha, Nebraska, 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
- DelRicht Research - Tulsa, Oklahoma, 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
- Re:Cognition Health - Fort Worth - Fort Worth, Texas, United States
- Synexus Clinical Research US, Inc. - San Antonio, Texas, United States
- SYNEXUS - Murray, Utah, United States
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →