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A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation

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Trial Profile

A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Feb 2022

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At a glance

  • Drugs Aprepitant/bupivacaine/meloxicam (Primary) ; Bupivacaine
  • Indications Postoperative pain
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Heron Therapeutics

Most Recent Events

  • 31 Jan 2022 Status changed from recruiting to completed.
  • 10 May 2021 According to a Heron Therapeutics media release, the company initiated the expanded Phase 2 part of the study in March 2021.
  • 12 Mar 2021 Experimental phase 2 dose D arm added in the treatment arms. Anticipated enrollment of patients increased from 32 to 72. Number of study treatment arms increased from 4 to 5.

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