Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

• Status: Completed
• Trial end date: 2019-08-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this phase 2 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivozon, Inc.

Criteria

Inclusion Criteria:

• Men and women must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential.

• Subjects must be undergoing a planned 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.

• Subjects must be classified as American Society of Anesthesiologists risk class I to II.

Exclusion Criteria:

• Subjects undergoing emergency or unplanned surgery.

• Subjects undergoing a repeat operation.

• 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.