En masterprotokolundersøgelse (LY900028) af multiple interventionsspecifikke appendikser (ISA'er) hos deltagere med kroniske smerter (CPMP)
3. november 2026 opdateret af: Eli Lilly and Company
En masterprotokol for randomiserede, placebokontrollerede, fase 2 kliniske forsøg med flere interventioner til behandling af kroniske smerter
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.
Studieoversigt
Status
Rekruttering
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
10000
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Rekruttering
- Central Research Associates
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Ledende efterforsker:
- David DeAtkine
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Kontakt:
- Telefonnummer: 205-327-1077
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Birmingham, Alabama, Forenede Stater, 35211
- Afsluttet
- Simon Williamson Clinic
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Arizona
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Glendale, Arizona, Forenede Stater, 85306
- Afsluttet
- Synexus Clinical Research - Glendale
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Phoenix, Arizona, Forenede Stater, 85053
- Rekruttering
- Arizona Research Center
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Kontakt:
- Telefonnummer: 602-863-6363
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Ledende efterforsker:
- Louise Taber MD
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Phoenix, Arizona, Forenede Stater, 85020
- Rekruttering
- Synexus Clinical Research US, Inc.
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Ledende efterforsker:
- Shawn Searle
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Tempe, Arizona, Forenede Stater, 85281
- Afsluttet
- Alliance for Multispecialty Research, LLC
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California
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Irvine, California, Forenede Stater, 92614
- Afsluttet
- Irvine Clinical Research
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Palm Springs, California, Forenede Stater, 92262
- Rekruttering
- Desert Oasis Healthcare Medical Group
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Kontakt:
- Telefonnummer: 760-320-9505
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Ledende efterforsker:
- Michael Jardula
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Riverside, California, Forenede Stater, 92503
- Rekruttering
- Artemis Institute for Clinical Research
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Kontakt:
- Telefonnummer: 951-374-1190
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Ledende efterforsker:
- Jack Vu
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- Artemis Institute for Clinical Research
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Kontakt:
- Telefonnummer: 858-278-3647
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Ledende efterforsker:
- Stacey Layle
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Connecticut
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Hamden, Connecticut, Forenede Stater, 06517
- Rekruttering
- CMR of Greater New Haven, LLC
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Ledende efterforsker:
- Jillian Reid
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Florida
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Aventura, Florida, Forenede Stater, 33180
- Afsluttet
- VIN-Julie Schwartzbard
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Bradenton, Florida, Forenede Stater, 34205
- Rekruttering
- Bradenton Research Center, Inc.
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Ledende efterforsker:
- Eric Folkens
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Kontakt:
- Telefonnummer: 941-708-0005
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Coral Gables, Florida, Forenede Stater, 33134
- Ikke rekrutterer endnu
- Clinical Research of South Florida
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Kontakt:
- Telefonnummer: 305-445-5637
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Ledende efterforsker:
- Jeffrey Rosen
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DeLand, Florida, Forenede Stater, 32720
- Rekruttering
- Accel Research Sites - DeLand Clinical Research Unit
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Ledende efterforsker:
- Bruce Rankin
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Kontakt:
- Telefonnummer: 205-757-8212
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Lady Lake, Florida, Forenede Stater, 32159
- Rekruttering
- K2 MEDICAL Research THE VILLAGES
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Ledende efterforsker:
- Craig Curtis
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Kontakt:
- Telefonnummer: 352-500-5252
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Maitland, Florida, Forenede Stater, 32751
- Rekruttering
- K2 Medical Research ORLANDO
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Kontakt:
- Telefonnummer: 407-500-5252
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Ledende efterforsker:
- Brandon Lenox
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Merritt Island, Florida, Forenede Stater, 32952
- Rekruttering
- Merritt Island Medical Research, LLC
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Ledende efterforsker:
- David Kirk
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Miami, Florida, Forenede Stater, 33165
- Rekruttering
- New Horizon Research Center
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Ledende efterforsker:
- Lazaro Nunez
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Kontakt:
- Telefonnummer: 305-226-3933
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Miami, Florida, Forenede Stater, 33136
- Ikke rekrutterer endnu
- University of Miami Don Suffer Clinical Research Building
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Kontakt:
- Telefonnummer: 305-243-8555
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Ledende efterforsker:
- Danielle Horn
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Flourish Research - Miami, LLC
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Ledende efterforsker:
- Mark Kutner
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Kontakt:
- Telefonnummer: 305-631-6704
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New Port Richey, Florida, Forenede Stater, 34652
- Rekruttering
- Suncoast Clinical Research, Inc.
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Kontakt:
- Telefonnummer: 727-849-4131
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Ledende efterforsker:
- Cathy Barnes
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Ocala, Florida, Forenede Stater, 34470
- Rekruttering
- Renstar Medical Research
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Kontakt:
- Telefonnummer: 352-629-5800
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Ledende efterforsker:
- David Oliver
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Orlando, Florida, Forenede Stater, 32806
- Ikke rekrutterer endnu
- Synexus Clinical Research US, Inc.
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Kontakt:
- Telefonnummer: 407-426-9299
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Ledende efterforsker:
- Beatriz Colon
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Pinellas Park, Florida, Forenede Stater, 33781
- Afsluttet
- Synexus Clinical Research - St. Petersburg
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Plantation, Florida, Forenede Stater, 33317
- Afsluttet
- Martin E. Hale M.D., P.A.
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Sunrise, Florida, Forenede Stater, 33351
- Rekruttering
- Precision Clinical Research
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Ledende efterforsker:
- Richard Linn
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The Villages, Florida, Forenede Stater, 32162
- Afsluttet
- Synexus Clinical Research US, Inc.
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The Villages, Florida, Forenede Stater, 32162
- Rekruttering
- Charter Research - Lady Lake
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Ledende efterforsker:
- Stephen Miller
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Winter Park, Florida, Forenede Stater, 32789
- Rekruttering
- Conquest Research
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Ledende efterforsker:
- Anand Patel
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Kontakt:
- Telefonnummer: 407-916-0060
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Georgia
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Woodstock, Georgia, Forenede Stater, 30189
- Rekruttering
- North Georgia Clinical Research
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Kontakt:
- Telefonnummer: 678-494-5735
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Ledende efterforsker:
- Bram Wieskopf
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Ikke rekrutterer endnu
- Rocky Mountain Clinical Research
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Kontakt:
- Telefonnummer: 208-522-6005
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Ledende efterforsker:
- Kevin Prier
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern University
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Kontakt:
- Telefonnummer: 312-503-2315
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Ledende efterforsker:
- Thomas Schnitzer
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Chicago, Illinois, Forenede Stater, 60602
- Afsluttet
- Synexus Clinical Research
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Afsluttet
- Cotton O'Neil Clinical Research Center - Central Office
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70115
- Rekruttering
- DelRicht Research
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Ledende efterforsker:
- Patrick Dennis
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Kontakt:
- Telefonnummer: 504-336-2667
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02131
- Ikke rekrutterer endnu
- Boston Clinical Trials
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Ledende efterforsker:
- Antonio Mendes
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Kontakt:
- Telefonnummer: 617-477-4868
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Methuen, Massachusetts, Forenede Stater, 01844
- Afsluttet
- ActivMed Practices and Research
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New Bedford, Massachusetts, Forenede Stater, 02740
- Rekruttering
- Lucida Clinical Trials
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Ledende efterforsker:
- David Shih
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Kontakt:
- Telefonnummer: 508-720-2015
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Waltham, Massachusetts, Forenede Stater, 02451
- Rekruttering
- MedVadis Research Corporation
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Kontakt:
- Telefonnummer: 617-744-1310
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Ledende efterforsker:
- David DiBenedetto
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Michigan
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Bay City, Michigan, Forenede Stater, 48706
- Rekruttering
- Great Lakes Research Group, Inc.
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Kontakt:
- Telefonnummer: 989-895-9100
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Ledende efterforsker:
- Jeffrey Potts
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63303
- Rekruttering
- StudyMetrix Research
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Kontakt:
- Telefonnummer: 636-387-5100
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Ledende efterforsker:
- Timothy Smith
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Springfield, Missouri, Forenede Stater, 65807
- Rekruttering
- Clinvest Research LLC
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Kontakt:
- Telefonnummer: 417-883-7889
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Ledende efterforsker:
- Cory Bethmann
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68144
- Afsluttet
- Synexus Clinical Research US, Inc.
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New York
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research, LLC
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Kontakt:
- Telefonnummer: 585-288-0890
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Ledende efterforsker:
- Patrick Connors
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27408
- Afsluttet
- PharmQuest
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58104
- Rekruttering
- Lillestol Research
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Ledende efterforsker:
- Michael Lillestol
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Kontakt:
- Telefonnummer: 701-232-7705
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45236
- Afsluttet
- Synexus - Cincinnati
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Columbus, Ohio, Forenede Stater, 43213
- Afsluttet
- Aventiv Research Inc
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Dayton, Ohio, Forenede Stater, 45432
- Rekruttering
- META Medical Research Institute
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Ledende efterforsker:
- Priyesh Mehta
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74133
- Rekruttering
- DelRicht Research
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Ledende efterforsker:
- Melita Tate
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Kontakt:
- Telefonnummer: 504-336-2667
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Pennsylvania
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Duncansville, Pennsylvania, Forenede Stater, 16635
- Rekruttering
- Altoona Center For Clinical Research
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Ledende efterforsker:
- Alan Kivitz
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Kontakt:
- Telefonnummer: 814-693-0300
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- Afsluttet
- Clinical Research Center of Reading,LLC
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Afsluttet
- Coastal Carolina Research Center
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Texas
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Austin, Texas, Forenede Stater, 78731
- Rekruttering
- FutureSearch Trials of Neurology
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Kontakt:
- Telefonnummer: 512-380-9925
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Ledende efterforsker:
- Gregory Tempest
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Dallas, Texas, Forenede Stater, 75251
- Afsluttet
- Cedar Health Research
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Dallas, Texas, Forenede Stater, 75234
- Afsluttet
- Synexus
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Fort Worth, Texas, Forenede Stater, 76104
- Afsluttet
- Re:Cognition Health - Fort Worth
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San Antonio, Texas, Forenede Stater, 78229
- Afsluttet
- Synexus Clinical Research US, Inc.
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Utah
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Murray, Utah, Forenede Stater, 84123
- Afsluttet
- SYNEXUS
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Rekruttering
- Northwest Clinical Research Center
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Kontakt:
- Telefonnummer: 425-453-0404
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Ledende efterforsker:
- Arifulla Khan, MD
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Renton, Washington, Forenede Stater, 98057
- Rekruttering
- Rainier Clinical Research Center
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Ledende efterforsker:
- Sheryl Marks
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Kontakt:
- Telefonnummer: 425-251-1722
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Ponce, Puerto Rico, 00716
- Rekruttering
- Ponce Medical School Foundation Inc.
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Ledende efterforsker:
- Elizabeth Barranco-Santana
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Kontakt:
- Telefonnummer: 1-787-840-2505
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San Juan, Puerto Rico, 00909
- Afsluttet
- Latin Clinical Trial Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LY3016859 Osteoarthritis ISA
Participants are randomized to receive either active LY3016859 or matching placebo |
Placebo administered IV Administered intravenously (IV) |
|
Eksperimentel: LY3016859 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo |
Placebo administered IV Administered intravenously (IV) |
|
Eksperimentel: LY3016859 Chronic Back Pain ISA
Participants are randomized to receive either active LY3016859 or matching placebo |
Placebo administered IV Administered intravenously (IV) |
|
Eksperimentel: LY3556050 Osteoarthritis ISA
Participants are randomized to receive either active LY3556050 or matching placebo |
Administered orally Placebo administered orally |
|
Eksperimentel: LY3556050 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo |
Administered orally Placebo administered orally |
|
Eksperimentel: LY3556050 Chronic Back Pain ISA
Participants are randomized to receive either active LY3556050 or matching placebo |
Administered orally Placebo administered orally |
|
Eksperimentel: LY3526318 Osteoarthritis ISA
Participants are randomized to receive either active LY3526318 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY3526318 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY3526318 Chronic Back Pain ISA
Participants are randomized to receive either active LY3526318 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY3857210 Osteoarthritis ISA
Participants are randomized to receive either active LY3857210 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY3857210 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY3857210 Chronic Back Pain ISA
Participants are randomized to receive either active LY3857210 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY4065967 Chronic Low Back Pain ISA
Participants are randomized to receive either active LY4065967 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY4065967 Osteoarthritis ISA
Participants are randomized to receive either active LY4065967 or matching placebo |
Placebo administered orally Administered orally |
|
Eksperimentel: LY4065967 Diabetic Neuropathic Pain ISA
Participants are randomized to receive either active LY4065967 or matching placebo |
Placebo administered orally Administered orally |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antal deltagere, der blev tildelt hver ISA
Tidsramme: Baseline, op til uge 8
|
Baseline, op til uge 8
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. januar 2020
Primær færdiggørelse (Anslået)
1. april 2027
Studieafslutning (Anslået)
1. april 2027
Datoer for studieregistrering
Først indsendt
1. august 2023
Først indsendt, der opfyldte QC-kriterier
1. august 2023
Først opslået (Faktiske)
14. august 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17511
- H0P-MC-CPMP (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD-delingstidsramme
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD-delingsadgangskriterier
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .