Phase 3 Efficacy and Safety Study of VVZ-149 Injections f... | NCT04430088

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

NCT04430088

Sponsor

Vivozon, Inc.

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Pain, Postoperative

Interventions

VVZ-149 Injections
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2020Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Jun 9, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VVZ-149 Injections	Experimental		Drug: VVZ-149 Injections
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VVZ-149 Injections	Drug	IV infusion of 1000 mg of VVZ-149	VVZ-149 Injections

Outcomes Module

Primary Outcomes

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)	Using Numeric Pain Rating Scale (NRS, 0-10)	0-12 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trial Operations	Contact	+1-609-269-9140		clinicaltrials@vivozon.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Clinical Trial Site	Recruiting	Phoenix	Arizona	85053	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided