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

Sponsor
Vivozon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03997838
Collaborator
(none)
307
Enrollment
5
Locations
2
Arms
3
Actual Duration (Months)
61.4
Patients Per Site
20.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: VVZ-149 Injections
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 23, 2019
Actual Primary Completion Date :
Aug 3, 2019
Actual Study Completion Date :
Aug 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: VVZ-149 Injections

Drug: VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
Other Names:
  • Opiranserin Injections

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    IV infusion of 0 mg of VVZ-149

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence [0-24 hours post-emergence]

    2. Total number of requests for rescue medication for 24 hours post-emergence [0-24 hours post-emergence]

    3. Total amount of rescue medication consumption for 12 hours post-emergence [0-12 hours post-emergence]

    4. Total amount of intra-operative fentanyl use [During surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Research Center Phoenix Arizona United States 85053
    2 Anaheim Clinical Trials Anaheim California United States 92801
    3 Midwest Clinical Research Center Dayton Ohio United States 45417
    4 Endeavor Clinical Trials San Antonio Texas United States 78229
    5 JBR Clinical Research Salt Lake City Utah United States 84107

    Sponsors and Collaborators

    • Vivozon, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vivozon, Inc.
    ClinicalTrials.gov Identifier:
    NCT03997838
    Other Study ID Numbers:
    • VVZ149-POP-P3-US003
    First Posted:
    Jun 25, 2019
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Aug 25, 2020