Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2021-01-31

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 bunionectomy.

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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

Eligibility Criteria

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Inclusion Criteria

* Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
* Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin bunionectomy) without collateral procedures.
* Subjects must have the ability to provide written informed consent.
* Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.

Exclusion Criteria

* Subjects undergoing emergency or unplanned surgery.
* Subjects who had any previous bunionectomy procedure on either foot.
* Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
* Female subjects who are pregnant or breastfeeding.
* Diagnosis of chronic pain and ongoing or frequent use of pain medications.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No