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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT03997812

Run by

Vivozon, Inc.

People needed

60

Starts

2019-05-23

Expected to finish

2019-08-21

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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