Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02372578
Status:
TERMINATED
Last Update Posted:
2019-03-26
First Post:
2015-02-21
Brief Title:
Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
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
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to futility analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None