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

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04430088

Enrollment

300

Registered

2020-06-12

Start date

2020-06-26

Completion date

2021-01-31

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGVVZ-149 Injections

IV infusion of 1000 mg of VVZ-149

DRUGPlacebo

IV infusion of 0 mg of VVZ-149

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)	0-12 hours post-dose	Using Numeric Pain Rating Scale (NRS, 0-10)

Secondary

Measure	Time frame
Time to onset of perceptible pain relief using the double stopwatch method	0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose	0-12 hours post-dose
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose	0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge	2 weeks after discharge

Countries

United States

Contacts

Primary ContactClinical Trial Operations

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026