Status:
UNKNOWN
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
Lead Sponsor:
Vivozon, Inc.
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04430088
Start Date
June 26 2020
End Date
January 1 2021
Last Update
July 23 2020
Active Locations (3)
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1
Arizona Clinical Trial Site
Phoenix, Arizona, United States, 85053
2
California Clinical Trial Site
Anaheim, California, United States, 92801
3
Texas Clinical Trial Site
San Antonio, Texas, United States, 78229