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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VVZ-149 Injections
Placebo
Sponsored by
Vivozon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

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

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.

Sites / Locations

  • Arizona Clinical Trial SiteRecruiting
  • California Clinical Trial SiteRecruiting
  • Texas Clinical Trial SiteRecruiting

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

Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Using Numeric Pain Rating Scale (NRS, 0-10)

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2020
Last Updated
July 22, 2020
Sponsor
Vivozon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04430088
Brief Title
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

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
No
Data Monitoring Committee
No

5. Study Description

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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

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
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
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Description
Using Numeric Pain Rating Scale (NRS, 0-10)
Time Frame
0-12 hours post-dose
Secondary Outcome Measure Information:
Title
Time to onset of perceptible pain relief using the double stopwatch method
Time Frame
0-12 hours post-dose
Title
Total number of rescue medication request between 0-12 hours post-dose
Time Frame
0-12 hours post-dose
Title
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
Time Frame
0-6 hours post-dose
Title
Proportion of patients who take prescription opioid after discharge
Time Frame
2 weeks after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Operations
Phone
+1-609-269-9140
Email
clinicaltrials@vivozon.com
Facility Information:
Facility Name
Arizona Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
California Clinical Trial Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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