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

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: VVZ-149 Injections; Drug: Placebo

• Registration Number: NCT04430088
• Lead Sponsor: Vivozon, Inc.

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 available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-12
• Study Start: 2020-06-26
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-12
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VVZ-149 Injections	VVZ-149 Injections	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose	0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge	2 weeks after discharge

Trial Locations

Locations (3)

Texas Clinical Trial Site; 🇺🇸 San Antonio, Texas, United States

California Clinical Trial Site; 🇺🇸 Anaheim, California, United States

Arizona Clinical Trial Site; 🇺🇸 Phoenix, Arizona, United States