A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT04094662
Last Updated: 2022-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
393 participants
INTERVENTIONAL
2019-09-18
2022-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mirogabalin
Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
Mirogabalin
Mirogabalin tablets for oral administration
Placebo
Placebo (14-weeks)
Placebo
Matching placebo tablets for oral administration
Interventions
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Mirogabalin
Mirogabalin tablets for oral administration
Placebo
Matching placebo tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Beijing Chaoyang Hospital, Capital Medical University
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Xuanwu Hospital Capital Medical University
Beijing, , China
Special Medical Center of Chinese PLA Rocket Force
Beijing, , China
Beijing PingGu Hospital
Beijing, , China
Cangzhou Central Hospital
Cangzhou, , China
Jilin Province People's Hospital
Changchun, , China
The First Hospital of Changsha
Changsha, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, , China
West China Hospital, Sichuan University
Chengdu, , China
The Fourth People's Hospital of Chongqing
Chongqing, , China
Affiliated Zhongshan Hospital of Dalian University
Dalian, , China
Foshan First People's Hospital
Foshan, , China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, , China
Guizhou Provincial People's Hospital
Guizhou, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Jiaxing Second Hospital
Jiaxing, , China
Jilin Central General Hospital
Jilin, , China
The First Affiliated Hospital of Jinzhou Medical University
Jingzhou, , China
Yunnan First People's Hospital
Kunming, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, , China
Jiangxi Pingxiang People's Hospital
Pingxiang, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Shanghai Huashan Hospital
Shanghai, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Yangpu Hospital,Tongji University
Shanghai, , China
Shanghai Pudong Hospital
Shanghai, , China
Central Hospital of Minhang District Shanghai
Shanghai, , China
Siping Central Hospital
Siping, , China
The First Hospital of Shanxi Medical University
Taiyuan, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
Wenzhou, , China
Renmin Hospital of Wuhan University (Hubei General Hospital)
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zigong Fourth People's Hospital
Zigong, , China
Countries
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References
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Guo X, Yu Y, Zhang Y, Sun L, Li Y, Song B, Hang L, Baba M, Wasaki Y, Kikumori K, Murayama E. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain. Pain Ther. 2024 Aug;13(4):937-952. doi: 10.1007/s40122-024-00617-2. Epub 2024 Jun 19.
Other Identifiers
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DS5565-A-A315
Identifier Type: -
Identifier Source: org_study_id
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