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

• Status: Recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivozon, Inc.

Criteria

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.