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Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

Recruiting
18 years and older
All
Phase 3

Overview

The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.

Eligibility

Inclusion Criteria:

  • Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
  • Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin bunionectomy) without collateral procedures.
  • Subjects must have the ability to provide written informed consent.
  • Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.

Key Exclusion Criteria:

  • Subjects undergoing emergency or unplanned surgery.
  • Subjects who had any previous bunionectomy procedure on either foot.
  • Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
  • Female subjects who are pregnant or breastfeeding.
  • Diagnosis of chronic pain and ongoing or frequent use of pain medications.

Study details
    Postoperative pain

NCT04430088

Vivozon, Inc.

16 February 2024

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