Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Phase 2 Completed 430 enrolled Heron Therapeutics

RandomizedParallel-groupDouble-blindTreatment

Summary

A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy

Timeline

Start: 2016-05
Primary completion: 2017-02
Completion: 2017-03

Publications

Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine HCI	Unknown	50 mg	Other
Subject	HTX-002	Unknown	60 mg	Other
Subject	HTX-002	Unknown	120 mg	Other
Subject	HTX-002	Unknown	200 mg	Other
Subject	HTX-009	Unknown	3.6 mg	Other
Subject	HTX-011A	Unknown	6 mg	Other
Subject	HTX-011A	Unknown	200 mg	Other
Subject	HTX-011B	Unknown	0.9 mg	Other
Subject	HTX-011B	Unknown	1.8 mg	Other
Subject	HTX-011B	Unknown	3.6 mg	Other
Subject	HTX-011B	Unknown	6 mg	Other
Subject	HTX-011B	Unknown	30 mg	Other
Subject	HTX-011B	Unknown	60 mg	Other
Subject	HTX-011B	Unknown	120 mg	Other
Subject	HTX-011B	Unknown	200 mg	Other

Indications

No indication recorded.