Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-02 @ 12:50 PM
Study NCT ID:
NCT03015532
Status:
COMPLETED
Last Update Posted:
2025-03-07
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Sponsor:
Heron Therapeutics
Organization:
Study Overview
Official Title:
A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty
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, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: