A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Central Research Associates
NOT_YET_RECRUITING
Birmingham
Simon Williamson Clinic
COMPLETED
Birmingham
Arizona
Synexus Clinical Research - Glendale
COMPLETED
Glendale
Arizona Research Center
RECRUITING
Phoenix
Central Phoenix Medical Clinic
RECRUITING
Phoenix
Alliance for Multispecialty Research, LLC
COMPLETED
Tempe
California
Irvine Clinical Research
COMPLETED
Irvine
Desert Oasis Healthcare Medical Group
NOT_YET_RECRUITING
Palm Springs
Artemis Institute for Clinical Research
RECRUITING
Riverside
Artemis Institute for Clinical Research
RECRUITING
San Diego
Connecticut
CMR of Greater New Haven
RECRUITING
Hamden
Florida
VIN-Julie Schwartzbard
COMPLETED
Aventura
Bradenton Research Center, Inc.
NOT_YET_RECRUITING
Bradenton
Clinical Research of South Florida
NOT_YET_RECRUITING
Coral Gables
Accel Research Sites - DeLand Clinical Research Unit
RECRUITING
Deland
K2 MEDICAL Research THE VILLAGES
NOT_YET_RECRUITING
Lady Lake
K2 Medical Research ORLANDO
NOT_YET_RECRUITING
Maitland
Merritt Island Medical Research, LLC
NOT_YET_RECRUITING
Merritt Island
New Horizon Research Center
RECRUITING
Miami
Suncoast Research Group
RECRUITING
Miami
University of Miami Don Suffer Clinical Research Building
NOT_YET_RECRUITING
Miami
Suncoast Clinical Research, Inc.
NOT_YET_RECRUITING
New Port Richey
Renstar Medical Research
RECRUITING
Ocala
Synexus Clinical Research US, Inc.
NOT_YET_RECRUITING
Orlando
Synexus Clinical Research - St. Petersburg
COMPLETED
Pinellas Park
Martin E. Hale M.D., P.A.
COMPLETED
Plantation
Precision Clinical Research
NOT_YET_RECRUITING
Sunrise
Charter Research - Lady Lake
NOT_YET_RECRUITING
The Villages
Synexus Clinical Research US, Inc.
COMPLETED
The Villages
Conquest Research
NOT_YET_RECRUITING
Winter Park
Georgia
North Georgia Clinical Research
RECRUITING
Woodstock
Idaho
Rocky Mountain Clinical Research
NOT_YET_RECRUITING
Idaho Falls
Illinois
Northwestern University
RECRUITING
Chicago
Synexus Clinical Research
COMPLETED
Chicago
Kansas
Cotton O'Neil Clinical Research Center - Central Office
COMPLETED
Topeka
Louisiana
DelRicht Research
NOT_YET_RECRUITING
New Orleans
Massachusetts
Boston Clinical Trials
NOT_YET_RECRUITING
Boston
ActivMed Practices and Research
COMPLETED
Methuen
Lucida Clinical Trials
NOT_YET_RECRUITING
New Bedford
MedVadis Research Corporation
RECRUITING
Waltham
Michigan
Great Lakes Research Group, Inc.
RECRUITING
Bay City
Missouri
StudyMetrix Research
RECRUITING
City Of Saint Peters
Clinvest Research LLC
RECRUITING
Springfield
North Carolina
PharmQuest
COMPLETED
Greensboro
North Dakota
Lillestol Research
RECRUITING
Fargo
Nebraska
Synexus Clinical Research US, Inc.
COMPLETED
Omaha
New York
Rochester Clinical Research, LLC
NOT_YET_RECRUITING
Rochester
Ohio
Synexus - Cincinnati
COMPLETED
Cincinnati
Aventiv Research Inc
COMPLETED
Columbus
META Medical Research Institute
RECRUITING
Dayton
Oklahoma
DelRicht Research
NOT_YET_RECRUITING
Tulsa
Pennsylvania
Altoona Center For Clinical Research
RECRUITING
Duncansville
Clinical Research Center of Reading,LLC
COMPLETED
Wyomissing
South Carolina
Coastal Carolina Research Center
COMPLETED
North Charleston
Texas
FutureSearch Trials of Neurology
RECRUITING
Austin
Cedar Health Research
COMPLETED
Dallas
Synexus
COMPLETED
Dallas
Re:Cognition Health - Fort Worth
NOT_YET_RECRUITING
Fort Worth
Synexus Clinical Research US, Inc.
COMPLETED
San Antonio
Utah
SYNEXUS
COMPLETED
Murray
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Rainier Clinical Research Center
RECRUITING
Renton
Other Locations
Puerto Rico
Ponce Medical School Foundation Inc.
RECRUITING
Ponce
Latin Clinical Trial Center
COMPLETED
San Juan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2020-01-30
Estimated Completion Date: 2027-04
Participants
Target number of participants: 10000
Treatments
Experimental: LY3016859 Osteoarthritis ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Experimental: LY3016859 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Experimental: LY3016859 Chronic Back Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo
Experimental: LY3556050 Osteoarthritis ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Experimental: LY3556050 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Experimental: LY3556050 Chronic Back Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo
Experimental: LY3526318 Osteoarthritis ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Experimental: LY3526318 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Experimental: LY3526318 Chronic Back Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo
Experimental: LY3857210 Osteoarthritis ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Experimental: LY3857210 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Experimental: LY3857210 Chronic Back Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company