A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Interventions
- Drug: Placebo
- Registration Number
- NCT04094662
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 393
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (14-weeks) Mirogabalin Mirogabalin Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
- Primary Outcome Measures
Name Time Method Average Daily Pain Score (ADPS) Baseline to Week 14 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
Name Time Method Patient Global Impression of Change at Week 14 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.
ADPS responder rate at Week 14 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) at Week 14 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.
Average Daily Sleep Interference score (ADSIS) at Week 14 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 at Week 14 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 at Week 14 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.
Trial Locations
- Locations (40)
Shanghai Pudong Hospital
🇨🇳Shanghai, China
Cangzhou Central Hospital
🇨🇳Cangzhou, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, China
Shanghai Tenth People's 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
Peace Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, China
The Fourth People's Hospital of Chongqing
🇨🇳Chongqing, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳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
The First Hospital of Changsha
🇨🇳Changsha, China
Jilin Province People's Hospital
🇨🇳Chang chun, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Foshan First People's Hospital
🇨🇳Foshan, China
Nanfang Hospital of Southern Medical Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jingzhou, China
Jilin Central General Hospital
🇨🇳Jilin, China
Yunnan First People's Hospital
🇨🇳Kunming, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
Guizhou Provincial People's Hospital
🇨🇳Guizhou, China
Jiaxing Second Hospital
🇨🇳Jiaxing, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, China
Luoyang Central Hospital Affiliated to Zhengzhou University
🇨🇳Luoyang, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Shanghai Huashan Hospital
🇨🇳Shanghai, China
Yangpu Hospital,Tongji University
🇨🇳Shanghai, 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
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, China
Wuxi People's Hospital
🇨🇳Wuxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Zigong Fourth People's Hospital
🇨🇳Zigong, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Peking University First Hospital
🇨🇳Beijing, China