Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
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
1 other identifier
interventional
307
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2019
CompletedFirst Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2019
CompletedAugust 25, 2020
August 1, 2020
2 months
May 28, 2019
August 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
0-12 hours post-emergence
Secondary Outcomes (4)
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 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
Total amount of intra-operative fentanyl use
During surgery
Study Arms (2)
VVZ-149 Injections
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
IV infusion of 1000 mg of VVZ-149
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vivozon, Inc.lead
Study Sites (5)
Arizona Research Center
Phoenix, Arizona, 85053, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Doo Lee, PhD
Vivozon, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2019
First Posted
June 25, 2019
Study Start
May 23, 2019
Primary Completion
August 3, 2019
Study Completion
August 21, 2019
Last Updated
August 25, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share