Clinical trial NCT04094662: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average Daily Pain Score (ADPS)
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: ADPS responder rate
timeFrame: at Week 14
measure: Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)
timeFrame: at Week 14
measure: Patient Global Impression of Change
timeFrame: at Week 14
measure: Average Daily Sleep Interference score (ADSIS)
timeFrame: at Week 14
measure: Medical Outcome Study (MOS) sleep scale
timeFrame: at Week 14
measure: Five Level EuroQol-5D (EQ-5D) version
timeFrame: at Week 14
Other outcomes:
measure: Actigraphy signal collected from a wrist-worn medical-grade sensor
timeFrame: at Week 14
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Special Medical Center of Chinese PLA Rocket Force
city: Beijing
country: China
facility: Beijing PingGu Hospital
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
city: Chang chun
country: China
facility: Jilin Province People's Hospital
city: Changsha
country: China
facility: The First Hospital of Changsha
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Changzhi
country: China
facility: Peace Hospital Affiliated to Changzhi Medical College
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The Fourth People's Hospital of Chongqing
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
city: Foshan
country: China
facility: Foshan First People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical Hospital
city: Guizhou
country: China
facility: Guizhou Provincial People's Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
city: Jilin
country: China
facility: Jilin Central General Hospital
city: Jingzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
city: Kunming
country: China
facility: Yunnan First People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Luoyang
country: China
facility: Luoyang Central Hospital Affiliated to Zhengzhou University
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Yangpu Hospital,Tongji University
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
city: Shanghai
country: China
facility: Central Hospital of Minhang District Shanghai
city: Siping
country: China
facility: Siping Central Hospital
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University (Hubei General Hospital)
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Zigong
country: China
facility: Zigong Fourth People's Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: