NCT02372578

Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo. The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).

Conditions

• Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions

Type	Name	Description
DRUG	ASP3662	oral
DRUG	pregabalin	oral
DRUG	ASP3662 placebo	oral
DRUG	pregabalin placebo	oral

Timeline

• Start date: 2015-05-27
• Primary completion: 2016-05-20
• Completion: 2016-05-20
• First posted: 2015-02-26
• Last updated: 2019-03-26

Locations

37 sites across 1 country: United States