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

Pain, Postoperative Clinical Trial

Official title:

A 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: Completed

Administrative data

• NCT number: NCT03997812
• Other study ID #: VVZ149-POP-P2-US004
• Status: Completed
• Phase: Phase 2
• Start date: May 23, 2019
• Est. completion date: August 21, 2019

Study information

• Verified date: August 2020
• Source: Vivozon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 21, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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	Anaheim Clinical Trials	Anaheim	California
United States	JBR Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Vivozon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)	0-12 hours after the start of study drug infusion
Secondary	AUC of pain intensity for 24 hours after the start of study drug infusion.		0-24 hours after the start of study drug infusion
Secondary	Total opioid consumption up to 12 hours after the start of study drug infusion.		0-12 hours after the start of study drug infusion
Secondary	Total opioid consumption up to 24 hours after the start of study drug infusion.		0-24 hours after the start of study drug infusion
Secondary	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
Secondary	Time until the subject requested first and second rescue medications.		0-24 hours after the start of study drug infusion
Secondary	Time to perceptible, meaningful, and confirmed perceptible pain relief.		0-12 hours after the start of study drug infusion