NCT02065349

A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety

A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.

Detailed description

The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.

Conditions

• Post-Herpetic Neuralgia (PHN)
• Neuropathic Pain
• Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions

Type	Name	Description
DRUG	ASP8477	oral
DRUG	Placebo	oral

Timeline

• Start date: 2014-02-24
• Primary completion: 2015-02-13
• Completion: 2015-02-13
• First posted: 2014-02-19
• Last updated: 2017-11-08

Locations

17 sites across 4 countries: Czechia, Germany, Poland, United Kingdom