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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mirogabalin
Placebo
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus at screening
  • Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Exclusion Criteria:

  • HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
  • Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
  • Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Major psychiatric disorders at screening or randomization
  • Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening

Sites / Locations

  • Beijing Chaoyang Hospital, Capital Medical University
  • Peking University First Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Xuanwu Hospital Capital Medical University
  • Special Medical Center of Chinese PLA Rocket Force
  • Beijing PingGu Hospital
  • Cangzhou Central Hospital
  • Jilin Province People's Hospital
  • The First Hospital of Changsha
  • The Second Xiangya Hospital of Central South University
  • Peace Hospital Affiliated to Changzhi Medical College
  • West China Hospital, Sichuan University
  • The Fourth People's Hospital of Chongqing
  • Affiliated Zhongshan Hospital of Dalian University
  • Foshan First People's Hospital
  • Nanfang Hospital of Southern Medical Hospital
  • Guizhou Provincial People's Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Jiaxing Second Hospital
  • Jilin Central General Hospital
  • The First Affiliated Hospital of Jinzhou Medical University
  • Yunnan First People's Hospital
  • The First Affiliated Hospital of Henan University of Science and Technology
  • Luoyang Central Hospital Affiliated to Zhengzhou University
  • Jiangxi Pingxiang People's Hospital
  • The Affiliated Hospital of Qingdao University
  • Shanghai Huashan Hospital
  • Shanghai Tenth People's Hospital
  • Yangpu Hospital,Tongji University
  • Shanghai Pudong Hospital
  • Central Hospital of Minhang District Shanghai
  • Siping Central Hospital
  • The First Hospital of Shanxi Medical University
  • The Second Hospital of Tianjin Medical University
  • The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
  • Renmin Hospital of Wuhan University (Hubei General Hospital)
  • Wuxi People's Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital of Xiamen University
  • Zigong Fourth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirogabalin

Placebo

Arm Description

Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.

Placebo (14-weeks)

Outcomes

Primary Outcome Measures

Average Daily Pain Score (ADPS)
The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.

Secondary Outcome Measures

ADPS responder rate
Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)
The VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.
Patient Global Impression of Change
Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates.
Average Daily Sleep Interference score (ADSIS)
The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.
Medical Outcome Study (MOS) sleep scale
Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire: Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5. Part 2 - The participants give the number of hours per night for the average hours of sleep per night. Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep.
Five Level EuroQol-5D (EQ-5D) version
Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health.

Full Information

First Posted
September 17, 2019
Last Updated
October 20, 2022
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04094662
Brief Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
Detailed Description
The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirogabalin
Arm Type
Experimental
Arm Description
Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (14-weeks)
Intervention Type
Drug
Intervention Name(s)
Mirogabalin
Other Intervention Name(s)
DS-5565
Intervention Description
Mirogabalin tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets for oral administration
Primary Outcome Measure Information:
Title
Average Daily Pain Score (ADPS)
Description
The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
ADPS responder rate
Description
Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.
Time Frame
at Week 14
Title
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)
Description
The VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.
Time Frame
at Week 14
Title
Patient Global Impression of Change
Description
Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates.
Time Frame
at Week 14
Title
Average Daily Sleep Interference score (ADSIS)
Description
The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.
Time Frame
at Week 14
Title
Medical Outcome Study (MOS) sleep scale
Description
Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire: Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5. Part 2 - The participants give the number of hours per night for the average hours of sleep per night. Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep.
Time Frame
at Week 14
Title
Five Level EuroQol-5D (EQ-5D) version
Description
Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health.
Time Frame
at Week 14
Other Pre-specified Outcome Measures:
Title
Actigraphy signal collected from a wrist-worn medical-grade sensor
Description
Result of physical activity during waking hours and participants' sleep will be evaluated to explore a relationship between participants reported outcomes and actigraphy signal collected from a wrist-worn medical-grade sensor (ActiGraph GT9X Link). Only participants who signed a separate informed consent form for wearing medical-grade sensor will be included in this evaluation.
Time Frame
at Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 or type 2 diabetes mellitus at screening Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details) Exclusion Criteria: HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP Major psychiatric disorders at screening or randomization Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Special Medical Center of Chinese PLA Rocket Force
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing PingGu Hospital
City
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
ZIP/Postal Code
061001
Country
China
Facility Name
Jilin Province People's Hospital
City
Chang chun
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
ZIP/Postal Code
410005
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Peace Hospital Affiliated to Changzhi Medical College
City
Changzhi
ZIP/Postal Code
046000
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The Fourth People's Hospital of Chongqing
City
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
ZIP/Postal Code
116001
Country
China
Facility Name
Foshan First People's Hospital
City
Foshan
ZIP/Postal Code
528000
Country
China
Facility Name
Nanfang Hospital of Southern Medical Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Guizhou Provincial People's Hospital
City
Guizhou
ZIP/Postal Code
550002
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Jiaxing Second Hospital
City
Jiaxing
ZIP/Postal Code
314000
Country
China
Facility Name
Jilin Central General Hospital
City
Jilin
ZIP/Postal Code
132011
Country
China
Facility Name
The First Affiliated Hospital of Jinzhou Medical University
City
Jingzhou
ZIP/Postal Code
121001
Country
China
Facility Name
Yunnan First People's Hospital
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
ZIP/Postal Code
471000
Country
China
Facility Name
Luoyang Central Hospital Affiliated to Zhengzhou University
City
Luoyang
ZIP/Postal Code
471009
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
ZIP/Postal Code
266071
Country
China
Facility Name
Shanghai Huashan Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Yangpu Hospital,Tongji University
City
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Shanghai Pudong Hospital
City
Shanghai
ZIP/Postal Code
200135
Country
China
Facility Name
Central Hospital of Minhang District Shanghai
City
Shanghai
ZIP/Postal Code
201199
Country
China
Facility Name
Siping Central Hospital
City
Siping
ZIP/Postal Code
136000
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325027
Country
China
Facility Name
Renmin Hospital of Wuhan University (Hubei General Hospital)
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Zigong Fourth People's Hospital
City
Zigong
ZIP/Postal Code
643000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

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