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Completed

NCT Number: NCT03997812

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VVZ-149 Injections

Drug

IV infusion of 1000 mg of VVZ-149

Other names: Opiranserin Injections

Placebo

Drug

IV infusion of 0 mg of VVZ-149

Primary outcomes

  1. Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion

    Time frame: 0-12 hours after the start of study drug infusion

    Using Numeric Pain Rating Scale (NRS, 0-10 at rest)

Secondary outcomes

  1. AUC of pain intensity for 24 hours after the start of study drug infusion.

    Time frame: 0-24 hours after the start of study drug infusion

  2. Total opioid consumption up to 12 hours after the start of study drug infusion.

    Time frame: 0-12 hours after the start of study drug infusion

  3. Total opioid consumption up to 24 hours after the start of study drug infusion.

    Time frame: 0-24 hours after the start of study drug infusion

  4. Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.

    Time frame: 0-24 hours after the start of study drug infusion

  5. Time until the subject requested first and second rescue medications.

    Time frame: 0-24 hours after the start of study drug infusion

  6. Time to perceptible, meaningful, and confirmed perceptible pain relief.

    Time frame: 0-12 hours after the start of study drug infusion

Sponsors and collaborators

Lead sponsor

Vivozon, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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