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 16 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 IdentifierNCT04430088
SponsorVivozon, Inc.
Last Modified on16 February 2024

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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