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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2019-08-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VVZ-149 Injections

Group Type EXPERIMENTAL

VVZ-149 Injections

Intervention Type DRUG

IV infusion of 1000 mg of VVZ-149

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion of 0 mg of VVZ-149

Interventions

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VVZ-149 Injections

IV infusion of 1000 mg of VVZ-149

Intervention Type DRUG

Placebo

IV infusion of 0 mg of VVZ-149

Intervention Type DRUG

Other Intervention Names

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Opiranserin Injections

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No