Status:
COMPLETED
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT04094662
Start Date
September 18 2019
End Date
January 24 2022
Last Update
October 24 2022
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China, 100020
2
Peking University First Hospital
Beijing, China, 100034
3
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
4
Xuanwu Hospital Capital Medical University
Beijing, China, 100053