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

Vivozon, Inc.5 sites in 1 country307 target enrollmentMay 23, 2019

ConditionsPain, Postoperative

InterventionsVVZ-149 Injections Placebo

DrugsVVZ-149 Injections Placebo

Overview

Phase: Phase 3
Intervention: VVZ-149 Injections
Conditions: Pain, Postoperative
Sponsor: Vivozon, Inc.
Enrollment: 307
Locations: 5
Primary Endpoint: Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 23, 2019

End Date

August 21, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vivozon, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

VVZ-149 Injections

Intervention: VVZ-149 Injections

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence

Time Frame: 0-12 hours post-emergence

Using Numeric Pain Rating Scale (NRS, 0-10 at rest)

Secondary Outcomes

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)
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 amount of intra-operative fentanyl use(During surgery)