Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-09 @ 10:24 AM
Study NCT ID:
NCT03011333
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2B Upper Extremity Nerve Block Study
Sponsor:
Heron Therapeutics
Organization:
Study Overview
Official Title:
A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
Status:
COMPLETED
Status Verified Date:
2025-02
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:
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
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?: