Back to resultsA Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3556050
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria: Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening. Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 at time of screening. Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history. Have a visual analog scale (VAS) pain value ≥40 and <95 during screening. Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument 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 allowed concomitant pain medication permitted per protocol, for the duration of the study Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive). Are men, or women able to abide by reproductive and contraceptive requirements. Exclusion Criteria: History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP. 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 had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. Have in the judgement 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 a positive HIV test result at screening. Have a surgery planned during the study for any reason. Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
Sites / Locations
- The Institute for Liver Health dba Arizona Clinical Trials
- Headlands Research - Scottsdale
- Orange Grove Family Practice
- Preferred Research Partners
- Hope Clinical Research, Inc.
- Valley Clinical Trials, Inc.
- Northern California Research - Sacramento
- CMR of Greater New Haven, LLCRecruiting
- Suncoast Research Group
- New Horizon Research Center
- Northwestern University
- Alliance for Multispecialty Research, LLC
- Alliance for Multispecialty Research, LLC
- MedVadis Research Corporation
- SKY Integrative Medical Center/SKYCRNG
- Alliance for Multispecialty Research, LLC
- StudyMetrix ResearchRecruiting
- Clinvest Research LLC
- Las Vegas Medical Research
- UniMed Center
- North Suffolk Neurology
- Lucas Research - Hickory
- Lucas Research, Inc
- Velocity Clinical Research, Medford
- Tristar Clinical Investigations
- Palmetto Clinical Research
- New Phase Research and DevelopmentRecruiting
- Trinity Clinical Research
- FutureSearch Trials of Neurology
- Juno Research
- Consano Clinical Research, LLC
- Velocity Clinical Research, Salt Lake City
- Northwest Clinical Research CenterRecruiting
- Rainier Clinical Research Center
- EDUMED - Broumov
- Diabet2 s.r.o., diabetologicka a interni ambulance
- DiaVize s.r.o.
- Neurologická Ambulance - Forbeli
- FLEDIP s.r.o.
- Vestra Clinics
- Agentura Science Pro
- Matsuyama Shimin Hospital
- Kikuchi Naika Clinic
- Kure Medical Center
- Japanese Red Cross Asahikawa Hospital
- Yokohama Minoru Clinic
- Medical Corporation Heishinkai OCROM Clinic
- Sugiura Internal Medicine Clinic
- Medical Corporation Sato Medical clinic
- Heishinkai Medical Group ToCROM Clinic
- Kunisaki Makoto Clinic
- Minamiosaka Hospital
- Jeonbuk National University Hospital
- Kangwon National University Hospital
- Sejong General Hospital
- Nowon Eulji Medical Center, Eulji University
- Konkuk University Medical Center
- Samsung Medical Center
- Eulji University Hospital
- Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
- MICS Centrum Medyczne Torun
- Medycyna Kliniczna
- Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
- NZOZ Diab-Endo-Met
- Osteo Medic sc A. Racewicz, J. Supronik
- Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
- Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
- Centrum Medyczne Pratia Katowice
- Pro Familia Altera
- NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
- Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
LY3556050 Dose 1
LY3556050 Dose 2
LY3556050 Dose 3
Placebo
Arm Description
Participants will receive LY3556050 orally.
Participants will receive LY3556050 orally.
Participants will receive LY3556050 orally.
Participants will receive placebo orally.
Outcomes
Primary Outcome Measures
Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)
Secondary Outcome Measures
Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a
Mean Change from Baseline for Pain Interference with Sleep
Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a
Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b
Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity
Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status
Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change
Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)
Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period
Pharmacokinetics (PK): Plasma Concentration of LY3556050
Full Information
NCT ID
NCT06074562
First Posted
October 3, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT06074562
Brief Title
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Official Title
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 15, 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2023 (Actual)
Primary Completion Date
January 17, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (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 main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
410 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3556050 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive LY3556050 orally.
Arm Title
LY3556050 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive LY3556050 orally.
Arm Title
LY3556050 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive LY3556050 orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo orally.
Intervention Type
Drug
Intervention Name(s)
LY3556050
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS)
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Pain Interference with Sleep
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change
Time Frame
Baseline, Week 12
Title
Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)
Time Frame
Baseline, Week 12
Title
Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period
Time Frame
Baseline to Week 12
Title
Pharmacokinetics (PK): Plasma Concentration of LY3556050
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 at time of screening.
Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.
Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument
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 allowed concomitant pain medication permitted per protocol, for the duration of the study
Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
Are men, or women able to abide by reproductive and contraceptive requirements.
Exclusion Criteria:
History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
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 had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
Have in the judgement 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 a positive HIV test result at screening.
Have a surgery planned during the study for any reason.
Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
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
The Institute for Liver Health dba Arizona Clinical Trials
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yessica Sachdeva
Facility Name
Headlands Research - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Joseph K. Douglas
Facility Name
Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Lee Pounds
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul E. Wylie
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hessam Aazami
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Mohammed Azizad
Facility Name
Northern California Research - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Young
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
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Kutner
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaro D. Nunez
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schnitzer
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard H. Egelhof
Facility Name
Alliance for Multispecialty Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark S. Adams
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
SKY Integrative Medical Center/SKYCRNG
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Livingston
Facility Name
Alliance for Multispecialty Research, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Sue Fanning, MD
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
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gregory True
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornell Calinescu
Facility Name
UniMed Center
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Liu
Facility Name
North Suffolk Neurology
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Spinner
Facility Name
Lucas Research - Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venkatarama Sekher Donepudi
Facility Name
Lucas Research, Inc
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Jean Lucas
Facility Name
Velocity Clinical Research, Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Imogene Smiley
Facility Name
Tristar Clinical Investigations
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Yeoman
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colby H. Grossman
Facility Name
New Phase Research and Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie L Clarke
Facility Name
Trinity Clinical Research
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinesh K Gupta
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Douglas Hudson
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damaris Vega
Facility Name
Consano Clinical Research, LLC
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Welch
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara E. Rizzardi
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
Nazia Rahman
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Eileen Broyles
Facility Name
EDUMED - Broumov
City
Broumov
State/Province
Náchod
ZIP/Postal Code
550 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alica Vesela
Facility Name
Diabet2 s.r.o., diabetologicka a interni ambulance
City
Praha
State/Province
Praha 1
ZIP/Postal Code
11000
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Hron
Facility Name
DiaVize s.r.o.
City
Praha
State/Province
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Klementova
Facility Name
Neurologická Ambulance - Forbeli
City
Praha
State/Province
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Bajacek
Facility Name
FLEDIP s.r.o.
City
Prague
State/Province
Praha, Hlavní Mešto
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Flekac
Facility Name
Vestra Clinics
City
European Union
State/Province
Rychnov Nad Kněžnou
ZIP/Postal Code
516 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladislav Pazdera
Facility Name
Agentura Science Pro
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Brychta
Facility Name
Matsuyama Shimin Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0067
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidenori Senb
Facility Name
Kikuchi Naika Clinic
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
370-3573
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Kikuchi
Facility Name
Kure Medical Center
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsunobu Kubota
Facility Name
Japanese Red Cross Asahikawa Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8530
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsuko Abiko
Facility Name
Yokohama Minoru Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chino Nakamura
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Inoue
Facility Name
Sugiura Internal Medicine Clinic
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0034
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatsushi Sugiura
Facility Name
Medical Corporation Sato Medical clinic
City
Ootaku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sato
Facility Name
Heishinkai Medical Group ToCROM Clinic
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamu Matsuoka
Facility Name
Kunisaki Makoto Clinic
City
Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Kunisaki
Facility Name
Minamiosaka Hospital
City
Osaka
ZIP/Postal Code
559-0012
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasurou Kumeda
Facility Name
Jeonbuk National University Hospital
City
Jeonju-si
State/Province
Jeonrabugdo
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Sun Park
Facility Name
Kangwon National University Hospital
City
Chuncheon-si
State/Province
Kang-won-do
ZIP/Postal Code
24289
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seon Mee Kang
Facility Name
Sejong General Hospital
City
Sosa-gu
State/Province
Kyǒnggi-do
ZIP/Postal Code
14754
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHONG HWA KIM
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
01830
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kyungwan Min
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeeyoung Oh
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ByoungJoon Kim
Facility Name
Eulji University Hospital
City
Daejeon
State/Province
Taejǒn-Kwangyǒkshi
ZIP/Postal Code
01830
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Hwa Hong
Facility Name
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-162
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Napora
Facility Name
MICS Centrum Medyczne Torun
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Ocicka-Kozakiewicz
Facility Name
Medycyna Kliniczna
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Szuflinska-Sidorowicz
Facility Name
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
City
Wyszkow
State/Province
Mazowieckie
ZIP/Postal Code
07-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Pieniazek
Facility Name
NZOZ Diab-Endo-Met
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
31-261
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Kwiatkowska
Facility Name
Osteo Medic sc A. Racewicz, J. Supronik
City
Biaystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Wasilewska
Facility Name
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marzenna Sekulska
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Jozefowska
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Siegel
Facility Name
Pro Familia Altera
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-648
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danuta Wronska
Facility Name
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
City
Ruda Slaska
State/Province
Śląskie
ZIP/Postal Code
41-709
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henryk Rudzki
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
City
Zabrze
State/Province
Śląskie
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Gumprecht
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/427360
Description
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Learn more about this trial
A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
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