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

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

VVZ-149 Injections

Placebo

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Anaheim Clinical Trials
JBR Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VVZ-149 Injections

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

AUC of pain intensity for 24 hours after the start of study drug infusion.

Total opioid consumption up to 12 hours after the start of study drug infusion.

Total opioid consumption up to 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.

Time until the subject requested first and second rescue medications.

Time to perceptible, meaningful, and confirmed perceptible pain relief.

Full Information

NCT ID

NCT03997812

First Posted

May 28, 2019

Last Updated

August 18, 2020

Sponsor

Vivozon, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03997812

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 23, 2019 (Actual)

Primary Completion Date

August 7, 2019 (Actual)

Study Completion Date

August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vivozon, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VVZ-149 Injections

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

VVZ-149 Injections

Other Intervention Name(s)

Opiranserin Injections

Intervention Description

IV infusion of 1000 mg of VVZ-149

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

IV infusion of 0 mg of VVZ-149

Primary Outcome Measure Information:

Title

Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion

Description

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

Time Frame

0-12 hours after the start of study drug infusion

Secondary Outcome Measure Information:

Title

AUC of pain intensity for 24 hours after the start of study drug infusion.

Time Frame

0-24 hours after the start of study drug infusion

Title

Total opioid consumption up to 12 hours after the start of study drug infusion.

Time Frame

0-12 hours after the start of study drug infusion

Title

Total opioid consumption up to 24 hours after the start of study drug infusion.

Time Frame

0-24 hours after the start of study drug infusion

Title

Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.

Time Frame

0-24 hours after the start of study drug infusion

Title

Time until the subject requested first and second rescue medications.

Time Frame

0-24 hours after the start of study drug infusion

Title

Time to perceptible, meaningful, and confirmed perceptible pain relief.

Time Frame

0-12 hours after the start of study drug infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doo Lee, PhD

Organizational Affiliation

Vivozon, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Anaheim Clinical Trials

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

JBR Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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