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

Vivozon

Status and phase

Unknown

Phase 3

Conditions

Pain, Postoperative

Treatments

Drug: VVZ-149 Injections

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04430088

VVZ149-POP-P3-US005

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.