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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT04430088

Run by

Vivozon, Inc.

People needed

300

Starts

2020-06-26

Expected to finish

2021-01-01

Last updated by the study team

2020-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Arizona Clinical Trial Site — Phoenix, Arizona, United States (enrolling)
• California Clinical Trial Site — Anaheim, California, United States (enrolling)
• Texas Clinical Trial Site — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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