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

NCT03997812 | Completed Phase 2 FDA Drug

• 1 other identifier: VVZ149-POP-P2-US004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

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

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

  0-12 hours after the start of study drug infusion

Secondary Outcomes (6)

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

  0-24 hours after the start of study drug infusion

• 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

• 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

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

  0-24 hours after the start of study drug infusion

Study Arms (2)

VVZ-149 Injections

EXPERIMENTAL

Drug: VVZ-149 Injections

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VVZ-149 Injections DRUG

IV infusion of 1000 mg of VVZ-149

Also known as: Opiranserin Injections

VVZ-149 Injections

Placebo DRUG

IV infusion of 0 mg of VVZ-149

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivozon, Inc.: lead

Study Sites (2)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Doo Lee, PhD

  Vivozon, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 25, 2019
• Study Start: May 23, 2019
• Primary Completion: August 7, 2019
• Study Completion: August 21, 2019
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)