A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
NCT04094662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393
Last updated 2022-10-24
Summary
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
Conditions
- Diabetic Peripheral Neuropathic Pain
Interventions
- DRUG
-
Mirogabalin
Mirogabalin tablets for oral administration
- DRUG
-
Matching placebo tablets for oral administration
Sponsors & Collaborators
-
Daiichi Sankyo Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Clinical Study Leader · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-18
- Primary Completion
- 2022-01-17
- Completion
- 2022-01-24
Countries
- China
Study Locations
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