Recruiting
Phase 3

VVZ-149

Sponsor:

Vivozon, Inc.

Code:

NCT04430088

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VVZ-149 Injections

Placebo

Study Details

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.

Conditions

Pain, Postoperative

Study ID

NCT04430088

Start date

Jun 26, 2020

Status verified date

Jun, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VVZ-149 Injections

placebo comparator: Placebo

Interventions

VVZ-149 Injections

IV infusion of 1000 mg of VVZ-149

Placebo

IV infusion of 0 mg of VVZ-149

Primary outcome measure

  • Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose) [ Time Frame: 0-12 hours post-dose ]

Central Contacts and Locations

Central contacts

Clinical Trial Operations

+1-609-269-9140clinicaltrials@vivozon.com

Locations

Arizona Clinical Trial Site

Recruiting

Phoenix, Arizona, United States, 85053

California Clinical Trial Site

Recruiting

Anaheim, California, United States, 92801

Texas Clinical Trial Site

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Vivozon, Inc.

Last update posted

Jul 23, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vivozon, Inc. on 2020-07-23.