---
title: Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
nct_id: NCT03997838
overall_status: COMPLETED
phase: PHASE3
sponsor: Vivozon, Inc.
study_type: INTERVENTIONAL
primary_condition: Pain, Postoperative
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03997838.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03997838"
ct_last_update_post_date: 2020-08-25
last_seen_at: "2026-05-12T07:31:07.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03997838](https://clinicaltrials.gov/study/NCT03997838)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 307
- **Lead Sponsor:** Vivozon, Inc.
- **Conditions:** Pain, Postoperative
- **Start Date:** 2019-05-23
- **Completion Date:** 2019-08-21
- **CT.gov Last Update:** 2020-08-25

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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
```

## Arms

- **VVZ-149 Injections** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **VVZ-149 Injections** (DRUG) — IV infusion of 1000 mg of VVZ-149
- **Placebo** (DRUG) — IV infusion of 0 mg of VVZ-149

## Primary Outcomes

- **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

- **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)_
- **Total number of requests for rescue medication for 24 hours post-emergence** _(time frame: 0-24 hours post-emergence)_
- **Total amount of rescue medication consumption for 12 hours post-emergence** _(time frame: 0-12 hours post-emergence)_
- **Total amount of intra-operative fentanyl use** _(time frame: During surgery)_

## Locations (5)

- Arizona Research Center, Phoenix, Arizona, United States
- Anaheim Clinical Trials, Anaheim, California, United States
- Midwest Clinical Research Center, Dayton, Ohio, United States
- Endeavor Clinical Trials, San Antonio, Texas, United States
- JBR Clinical Research, Salt Lake City, Utah, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.arizona research center|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.anaheim clinical trials|anaheim|california|united states` — added _(2026-05-12)_
- `locations.midwest clinical research center|dayton|ohio|united states` — added _(2026-05-12)_
- `locations.endeavor clinical trials|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.jbr clinical research|salt lake city|utah|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03997838.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03997838*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*