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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03997838

Run by

Vivozon, Inc.

People needed

307

Starts

2019-05-23

Expected to finish

2019-08-21

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States
• JBR Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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