NCT02318719

DS-5565 Phase III Study for Post-herpetic Neuralgia

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 765 (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 Post-Herpetic Neuralgia (PHN) 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 PHN 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 PHN.

Conditions

• Post-Herpetic Neuralgia

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	DS-5565

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2014-12-17
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

1 site across 1 country: Japan