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Completed

NCT Number: NCT03997838

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VVZ-149 Injections

Drug

IV infusion of 1000 mg of VVZ-149

Other names: Opiranserin Injections

Placebo

Drug

IV infusion of 0 mg of VVZ-149

Primary outcomes

  1. 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

  1. 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

  2. Total number of requests for rescue medication for 24 hours post-emergence

    Time frame: 0-24 hours post-emergence

  3. Total amount of rescue medication consumption for 12 hours post-emergence

    Time frame: 0-12 hours post-emergence

  4. Total amount of intra-operative fentanyl use

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

Vivozon, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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