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

Vivozon

Status and phase

Completed

Phase 2

Conditions

Pain, Postoperative

Treatments

Drug: VVZ-149 Injections

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03997812

VVZ149-POP-P2-US004

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.