NCT02318706

DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 854 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	DS-5565
DRUG	placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-29
• Completion: 2017-06-29
• First posted: 2014-12-17
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

1 site across 1 country: Japan