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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03997838

Enrollment

307

Registered

2019-06-25

Start date

2019-05-23

Completion date

2019-08-21

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGVVZ-149 Injections

IV infusion of 1000 mg of VVZ-149

DRUGPlacebo

IV infusion of 0 mg of VVZ-149

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026