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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: VVZ-149 Injections

• Registration Number: NCT03997838
• Lead Sponsor: Vivozon, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-25
• Primary Completion: 2019-08-03
• Study Completion: 2019-08-21
• Status Verified: 2020-08
• Disposition First Submitted: 2020-08-11
• Disposition First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Disposition First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
VVZ-149 Injections	VVZ-149 Injections	-

Primary Outcome Measures

Name	Time	Method
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence	0-12 hours post-emergence	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence	0-24 hours post-emergence
Total number of requests for rescue medication for 24 hours post-emergence	0-24 hours post-emergence
Total amount of rescue medication consumption for 12 hours post-emergence	0-12 hours post-emergence
Total amount of intra-operative fentanyl use	During surgery

Trial Locations

Locations (5)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Midwest Clinical Research Center; 🇺🇸 Dayton, Ohio, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States