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

Pain, Postoperative Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled Trial to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03997838
• Other study ID #: VVZ149-POP-P3-US003
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: August 21, 2019

Study information

• Verified date: August 2020
• Source: Vivozon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 21, 2019
• Est. primary completion date: August 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
• Placebo
IV infusion of 0 mg of VVZ-149

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vivozon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)	0-12 hours post-emergence
Secondary	Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence		0-24 hours post-emergence
Secondary	Total number of requests for rescue medication for 24 hours post-emergence		0-24 hours post-emergence
Secondary	Total amount of rescue medication consumption for 12 hours post-emergence		0-12 hours post-emergence
Secondary	Total amount of intra-operative fentanyl use		During surgery