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

August 18, 2020 updated by: Vivozon, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Arizona Research Center
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
IV infusion of 0 mg of VVZ-149
Experimental: VVZ-149 Injections
Drug: VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
Other Names:
  • Opiranserin Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0-12 hours post-emergence

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivozon, Inc.

Investigators

  • Study Chair: Doo Lee, PhD, Vivozon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Actual)

August 3, 2019

Study Completion (Actual)

August 21, 2019

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVZ149-POP-P3-US003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on VVZ-149 Injections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe