Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02065349
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2014-02-13
Brief Title:
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy and Its Safety
Sponsor:
Astellas Pharma Europe BV
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOBILE
Brief 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002521-27 | EUDRACT_NUMBER | None | None |