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

V

Vivozon

Status and phase

Unknown
Phase 3

Conditions

Pain, Postoperative

Treatments

Drug: VVZ-149 Injections
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04430088
VVZ149-POP-P3-US005

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 2 patient groups, including a placebo group

VVZ-149 Injections
Experimental group
Treatment:
Drug: VVZ-149 Injections
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Clinical Trial Operations

Data sourced from clinicaltrials.gov

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