Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

• Status: Completed
• Trial end date: 2019-08-21
• 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 abdominoplasty.

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

Details

• Lead Sponsor: Vivozon, Inc.

Criteria

Inclusion Criteria:

• Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential.

• Planning to undergo abdominoplasty

• Ability to provide written informed consent

• Ability to understand study procedures and communicate clearly with the investigator and staff

• American Society of Anesthesiologists (ASA) risk class of I to II.

Exclusion Criteria:

• Emergency or unplanned surgery

• Previous abdominoplasty

• Pre-existing condition causing preoperative pain around the site of surgery

• Women who are pregnant or breastfeeding

• Chronic pain diagnosis and ongoing or frequent use of pain medications