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A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

Primary Purpose

Chronic Pain, Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3857210
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

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

Inclusion Criteria: Males and females may participate in this trial. No male contraception is required except in compliance with specific local government study requirements. Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage. Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2. evidence of Hepatitis B virus or Hepatitis C virus. Women who are pregnant or breastfeeding.

Sites / Locations

  • Synexus Clinical Research US, Inc.
  • Arizona Research Center
  • Artemis Institute for Clinical Research
  • Artemis Institute for Clinical Research
  • CMR of Greater New Haven, LLC
  • Accel Research Sites- Clinical Research Unit
  • Suncoast Research Group
  • University of Miami Don Suffer Clinical Research Building
  • New Horizon Research Center
  • Renstar Medical Research
  • Synexus Clinical Research US, Inc - Orlando
  • Synexus Clinical Research US, Inc.
  • North Georgia Clinical Research
  • Rocky Mountain Clinical Research
  • Northwestern University
  • Boston Clinical Trials
  • ActivMed Practices and Research
  • MedVadis Research Corporation
  • Great Lakes Research Group, Inc.
  • StudyMetrix Research
  • Clinvest Headlands Llc
  • Lillestol Research
  • META Medical Research Institute
  • Altoona center for clinical research
  • FutureSearch Trials of Neurology
  • Synexus Clinical Research - St. Petersburg
  • Northwest Clinical Research Center
  • Rainier Clinical Research Center
  • Ponce Medical School Foundation Inc.
  • Latin Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3857210

Placebo

Arm Description

Participants will be given LY3857210 orally.

Participants will be given placebo orally.

Outcomes

Primary Outcome Measures

Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

Secondary Outcome Measures

Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score
Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Change from Baseline for Worst Pain Intensity as Measured by NRS
Change from Baseline on the Visual Analog Scale (VAS) for Pain
Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L)

Full Information

First Posted
November 11, 2022
Last Updated
August 28, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05620576
Brief Title
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)
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
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

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
This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3857210
Arm Type
Experimental
Arm Description
Participants will be given LY3857210 orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be given placebo orally.
Intervention Type
Drug
Intervention Name(s)
LY3857210
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Time Frame
Baseline, Up to Week 8
Secondary Outcome Measure Information:
Title
Change from Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Total Interference Score
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline for Worst Pain Intensity as Measured by NRS
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline on the Visual Analog Scale (VAS) for Pain
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline on the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)
Time Frame
Baseline, Up to Week 8
Title
Change from Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L)
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: Males and females may participate in this trial. No male contraception is required except in compliance with specific local government study requirements. Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage. Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2. evidence of Hepatitis B virus or Hepatitis C virus. Women who are pregnant or breastfeeding.
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
Synexus Clinical Research US, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
CMR of Greater New Haven, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
University of Miami Don Suffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Synexus Clinical Research US, Inc - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Headlands Llc
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
META Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Altoona center for clinical research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Synexus Clinical Research - St. Petersburg
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

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/
Links:
URL
https://trials.lilly.com/en-US/trial/368106
Description
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

Learn more about this trial

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05)

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