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DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:
An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension

Clinical Trial Summary

Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Clinical Trial Description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo. [Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02318706
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2015
Completion date June 29, 2017
View Details
See also
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