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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VVZ-149 Injections
Placebo
Sponsored by
Vivozon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Research Center
  • Anaheim Clinical Trials
  • Midwest Clinical Research Center
  • Endeavor Clinical Trials
  • JBR Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VVZ-149 Injections

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2019
Last Updated
August 18, 2020
Sponsor
Vivozon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03997838
Brief Title
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
August 3, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivozon, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VVZ-149 Injections
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VVZ-149 Injections
Other Intervention Name(s)
Opiranserin Injections
Intervention Description
IV infusion of 1000 mg of VVZ-149
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion of 0 mg of VVZ-149
Primary Outcome Measure Information:
Title
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
Description
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
Time Frame
0-12 hours post-emergence
Secondary Outcome Measure Information:
Title
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
Title
Total number of requests for rescue medication for 24 hours post-emergence
Time Frame
0-24 hours post-emergence
Title
Total amount of rescue medication consumption for 12 hours post-emergence
Time Frame
0-12 hours post-emergence
Title
Total amount of intra-operative fentanyl use
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo Lee, PhD
Organizational Affiliation
Vivozon, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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