Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

A 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

The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: VVZ-149 Injections; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential.
• Subjects must be undergoing a planned 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.
• Subjects must be classified as American Society of Anesthesiologists risk class I to II.

Exclusion Criteria:

• Subjects undergoing emergency or unplanned surgery.
• Subjects undergoing a repeat operation.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; IV infusion of 0 mg of VVZ-149
Experimental: VVZ-149 Injections	Drug: VVZ-149 Injections; IV infusion of 1000 mg of VVZ-149; Other Names: Opiranserin Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)	0-12 hours after the start of study drug infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC of pain intensity for 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
Total opioid consumption up to 12 hours after the start of study drug infusion.	0-12 hours after the start of study drug infusion
Total opioid consumption up to 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.	0-24 hours after the start of study drug infusion
Time until the subject requested first and second rescue medications.	0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.	0-12 hours after the start of study drug infusion

Collaborators and Investigators

• Sponsor: Vivozon, Inc.
• Investigators: Study Chair: Doo Lee, PhD, Vivozon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Actual): August 7, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: VVZ149-POP-P2-US004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No