Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

A 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

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03997812

Enrollment

Registered

2019-06-25

Start date

2019-05-23

Completion date

2019-08-21

Last updated

2020-08-25

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 2 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 70 Years

Healthy volunteers

Inclusion criteria

* Men and women must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential. * Subjects must be undergoing a planned 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. * Subjects must be classified as American Society of Anesthesiologists risk class I to II.

Exclusion criteria

* Subjects undergoing emergency or unplanned surgery. * Subjects undergoing a repeat operation. * 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
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion	0-12 hours after the start of study drug infusion	Using Numeric Pain Rating Scale (NRS, 0-10 at rest)

Secondary

Measure	Time frame
Total opioid consumption up to 12 hours after the start of study drug infusion.	0-12 hours after the start of study drug infusion
Total opioid consumption up to 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
AUC of pain intensity for 24 hours after the start of study drug infusion.	0-24 hours after the start of study drug infusion
Time until the subject requested first and second rescue medications.	0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.	0-12 hours after the start of study drug infusion
Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.	0-24 hours after the start of study drug infusion

Countries

United States

Outcome results

None listed

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