Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-28 @ 3:26 AM
Study NCT ID:
NCT02720692
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of N1539 Following Major Surgery
Sponsor:
Baudax Bio
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
Status:
COMPLETED
Status Verified Date:
2023-05
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:
None
Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: