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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430088
• Other study ID #: VVZ149-POP-P3-US005
• Status: Recruiting
• Phase: Phase 3
• Start date: June 26, 2020
• Est. completion date: January 2021

Study information

• Verified date: June 2020
• Source: Vivozon, Inc.
• Contact: Clinical Trial Operations
• Phone: +1-609-269-9140
• Email: clinicaltrials[@]vivozon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
• Placebo
IV infusion of 0 mg of VVZ-149

Locations

Country	Name	City	State
United States	California Clinical Trial Site	Anaheim	California
United States	Arizona Clinical Trial Site	Phoenix	Arizona
United States	Texas Clinical Trial Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vivozon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to onset of perceptible pain relief using the double stopwatch method		0-12 hours post-dose
Secondary	Total number of rescue medication request between 0-12 hours post-dose		0-12 hours post-dose
Secondary	Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose		0-6 hours post-dose
Secondary	Proportion of patients who take prescription opioid after discharge		2 weeks after discharge