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

STATUS

Recruiting
participants needed

300
sponsor

Vivozon, Inc.

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Updated on 19 February 2024

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postoperative pain

analgesics

internal fixation

bunionectomy

Summary

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.

Details

Condition	Postoperative pain
Age	18years - 100years
Treatment	Placebo, VVZ-149 Injections
Clinical Study Identifier	NCT04430088
Sponsor	Vivozon, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
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

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