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

Phase 2

Completed

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

• Registration Number: NCT03997812
• Lead Sponsor: Vivozon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-25
• Primary Completion: 2019-08-07
• Study Completion: 2019-08-21
• Status Verified: 2020-08
• Disposition First Submitted: 2020-08-11
• Disposition First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Disposition First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion	0-12 hours after the start of study drug infusion	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)

Secondary Outcome Measures

Name	Time	Method
AUC of pain intensity for 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
Total opioid consumption up to 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.	0-12 hours after the start of study drug infusion
Total opioid consumption up to 12 hours after the start of study drug infusion.	0-12 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.	0-24 hours after the start of study drug infusion
Time until the subject requested first and second rescue medications.	0-24 hours after the start of study drug infusion

Trial Locations

Locations (2)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

JBR Clinical Research; 🇺🇸 Salt Lake City, Utah, United States