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

July 22, 2020 updated by: Vivozon, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Recruiting
        • Arizona Clinical Trial Site
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • California Clinical Trial Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Texas Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0-12 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset of perceptible pain relief using the double stopwatch method
Time Frame: 0-12 hours post-dose
0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose
Time Frame: 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
Time Frame: 0-6 hours post-dose
0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge
Time Frame: 2 weeks after discharge
2 weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivozon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVZ149-POP-P3-US005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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