A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

Vivozon, Inc.3 sites in 1 country300 target enrollmentJune 26, 2020

ConditionsPain, Postoperative

InterventionsVVZ-149 Injections Placebo

DrugsVVZ-149 Injections Placebo

Overview

Phase: Phase 3
Intervention: VVZ-149 Injections
Conditions: Pain, Postoperative
Sponsor: Vivozon, Inc.
Enrollment: 300
Locations: 3
Primary Endpoint: Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 bunionectomy.

Registry

clinicaltrials.gov

Start Date

June 26, 2020

End Date

January 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vivozon, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

VVZ-149 Injections

Intervention: VVZ-149 Injections

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)

Time Frame: 0-12 hours post-dose

Using Numeric Pain Rating Scale (NRS, 0-10)

Secondary Outcomes

Time to onset of perceptible pain relief using the double stopwatch method(0-12 hours post-dose)
Total number of rescue medication request between 0-12 hours post-dose(0-12 hours post-dose)
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose(0-6 hours post-dose)
Proportion of patients who take prescription opioid after discharge(2 weeks after discharge)