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

Primary Purpose

Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3016859 ISA
LY3556050 ISA
LY3526318 ISA
LY3857210 ISA
Placebo Oral
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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 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.

Sites / Locations

  • Simon Williamson Clinic
  • Synexus Clinical Research - Glendale
  • Central Phoenix Medical ClinicRecruiting
  • Arizona Research CenterRecruiting
  • Alliance for Multispecialty Research, LLC
  • Irvine Clinical Research
  • Artemis Institute for Clinical ResearchRecruiting
  • Artemis Institute for Clinical ResearchRecruiting
  • CMR of Greater New Haven, LLCRecruiting
  • VIN-Julie Schwartzbard
  • Accel Research Sites- Clinical Research UnitRecruiting
  • Encore Research Group- Jacksonville Center for Clinical Research
  • Suncoast Research GroupRecruiting
  • University of Miami Don Suffer Clinical Research BuildingRecruiting
  • New Horizon Research CenterRecruiting
  • Renstar Medical ResearchRecruiting
  • Synexus Clinical Research US, Inc.Recruiting
  • Synexus Clinical Research - St. PetersburgRecruiting
  • Martin E. Hale M.D., P.A.
  • Synexus Clinical Research US, Inc.
  • North Georgia Clinical ResearchRecruiting
  • Rocky Mountain Clinical ResearchRecruiting
  • Synexus Clinical Research
  • Northwestern UniversityRecruiting
  • Cotton O'Neil Clinical Research Center - Central Office
  • Boston Clinical TrialsRecruiting
  • ActivMed Practices and ResearchRecruiting
  • MedVadis Research CorporationRecruiting
  • Great Lakes Research Group, Inc.Recruiting
  • StudyMetrix ResearchRecruiting
  • Clinvest Research LLCRecruiting
  • Synexus Clinical Research US, Inc.
  • PharmQuest
  • Lillestol ResearchRecruiting
  • Synexus - Cincinnati
  • Aventiv Research Inc
  • META Medical Research InstituteRecruiting
  • Altoona center for clinical researchRecruiting
  • Clinical Research Center of Reading,LLC
  • Coastal Carolina Research Center
  • FutureSearch Trials of NeurologyRecruiting
  • Synexus
  • Cedar Health Research
  • Synexus Clinical Research US, Inc.Recruiting
  • SYNEXUS
  • Northwest Clinical Research CenterRecruiting
  • Rainier Clinical Research CenterRecruiting
  • Ponce Medical School Foundation Inc.Recruiting
  • Latin Clinical Trial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

LY3016859 Osteoarthritis ISA

LY3016859 Diabetic Neuropathic Pain ISA

LY3016859 Chronic Back Pain ISA

LY3556050 Osteoarthritis ISA

LY3556050 Diabetic Neuropathic Pain ISA

LY3556050 Chronic Back Pain ISA

LY3526318 Osteoarthritis ISA

LY3526318 Diabetic Neuropathic Pain ISA

LY3526318 Chronic Back Pain ISA

LY3857210 Osteoarthritis ISA

LY3857210 Diabetic Neuropathic Pain ISA

LY3857210 Chronic Back Pain ISA

Arm Description

Participants are randomized to receive either active LY3016859 or matching placebo

Participants are randomized to receive either active LY3016859 or matching placebo

Participants are randomized to receive either active LY3016859 or matching placebo

Participants are randomized to receive either active LY3556050 or matching placebo

Participants are randomized to receive either active LY3556050 or matching placebo

Participants are randomized to receive either active LY3556050 or matching placebo

Participants are randomized to receive either active LY3526318 or matching placebo

Participants are randomized to receive either active LY3526318 or matching placebo

Participants are randomized to receive either active LY3526318 or matching placebo

Participants are randomized to receive either active LY3857210 or matching placebo

Participants are randomized to receive either active LY3857210 or matching placebo

Participants are randomized to receive either active LY3857210 or matching placebo

Outcomes

Primary Outcome Measures

Number of Participants Who Were Allocated to Each ISA

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05986292
Brief Title
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Acronym
CPMP
Official Title
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
April 25, 2027 (Anticipated)
Study Completion Date
April 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3016859 Osteoarthritis ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3016859 or matching placebo
Arm Title
LY3016859 Diabetic Neuropathic Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3016859 or matching placebo
Arm Title
LY3016859 Chronic Back Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3016859 or matching placebo
Arm Title
LY3556050 Osteoarthritis ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3556050 or matching placebo
Arm Title
LY3556050 Diabetic Neuropathic Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3556050 or matching placebo
Arm Title
LY3556050 Chronic Back Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3556050 or matching placebo
Arm Title
LY3526318 Osteoarthritis ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3526318 or matching placebo
Arm Title
LY3526318 Diabetic Neuropathic Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3526318 or matching placebo
Arm Title
LY3526318 Chronic Back Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3526318 or matching placebo
Arm Title
LY3857210 Osteoarthritis ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3857210 or matching placebo
Arm Title
LY3857210 Diabetic Neuropathic Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3857210 or matching placebo
Arm Title
LY3857210 Chronic Back Pain ISA
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active LY3857210 or matching placebo
Intervention Type
Drug
Intervention Name(s)
LY3016859 ISA
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
LY3556050 ISA
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
LY3526318 ISA
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
LY3857210 ISA
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo Oral
Intervention Description
Placebo administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered IV
Primary Outcome Measure Information:
Title
Number of Participants Who Were Allocated to Each ISA
Time Frame
Baseline, Up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Simon Williamson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Individual Site Status
Completed
Facility Name
Synexus Clinical Research - Glendale
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Completed
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elysa Shaw
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise A. Taber MD
Facility Name
Alliance for Multispecialty Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Completed
Facility Name
Irvine Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Completed
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Bailey Vu
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Layle
Facility Name
CMR of Greater New Haven, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Soufer
Facility Name
VIN-Julie Schwartzbard
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Completed
Facility Name
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce G Rankin
Facility Name
Encore Research Group- Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Completed
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Eliot Kutner
Facility Name
University of Miami Don Suffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Horn
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaro D. Nunez
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lucius Oliver
Facility Name
Synexus Clinical Research US, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Colon
Facility Name
Synexus Clinical Research - St. Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Murray
Facility Name
Martin E. Hale M.D., P.A.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Individual Site Status
Completed
Facility Name
Synexus Clinical Research US, Inc.
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Individual Site Status
Completed
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bram Wieskopf
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin T Prier
Facility Name
Synexus Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Individual Site Status
Completed
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schnitzer
Facility Name
Cotton O'Neil Clinical Research Center - Central Office
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Completed
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Mendes
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J. McCartney
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Potts
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Smith
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gregory True
Facility Name
Synexus Clinical Research US, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Completed
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Individual Site Status
Completed
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Lillestol
Facility Name
Synexus - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Completed
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Completed
Facility Name
META Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyesh Mehta
Facility Name
Altoona center for clinical research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Kivitz
Facility Name
Clinical Research Center of Reading,LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Completed
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Douglas Hudson
Facility Name
Synexus
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Completed
Facility Name
Cedar Health Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Completed
Facility Name
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilario Alvarado
Facility Name
SYNEXUS
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Eileen Broyles
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Barranco-Santana
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Pantojas-Concepcion

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Sharing Time Frame
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 Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/

Learn more about this trial

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

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