Phase 3 Efficacy and Safety of VVZ-149 Injections for Postoperative Pain Following Laparoscopic Colectomy

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 Laparoscopic Colectomy

The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following laparoscopic colectomy.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Acute Pain
• Intervention / Treatment: Drug: VVZ-149 Injections; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women who are at least 18 years of age
• Female subjects who are not pregnant or breastfeeding
• Subjects undergoing a planned first laparoscopic colectomy
• Subjects classified in American Society of Anesthesiologists (ASA) risk class of I or II
• Subjects who report the pain intensity ≥ 5 on the NRS measured after surgery
• Subjects who have the ability to understand study procedures and communicate clearly with the investigator and staff
• Subjects who provide written informed consent prior to participation in the study

Key Exclusion Criteria:

• Subjects undergoing emergency or unplanned surgery
• Subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure
• Subjects with pre-existing conditions causing preoperative pain at the site of surgery
• Female subjects who are pregnant or breastfeeding
• Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ≥ 5 at baseline)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; IV infusion of 0 mg of VVZ-149
Experimental: VVZ-149 Injections	Drug: VVZ-149 Injections; IV infusion of 1000 mg of VVZ-149; Other Names: Opiranserin Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-weighted Sum of Pain Intensity Differences for 12 hours post-dose (SPID 12)	Using Numeric Pain Rating Scale (NRS, 0-10)	0-12 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of patient-controlled analgesia (PCA) requests for 12 hours post-dose	0-12 hours post-dose
Total amount of PCA and rescue medication consumption for 12 hours post-dose	0-12 hours post-dose
Proportion of subjects with ≥ 40% decrease in pain area at 6 hours post-dose compared to the maximum pain area with the pre-dose pain intensity	0-6 hours post-dose
Time-weighted SPID for 24 hours post-dose (SPID 24)	0-24 hours post-dose

Collaborators and Investigators

• Sponsor: Vivozon Pharmaceutical Inc.
• Investigators: Study Chair: Doo Lee, PhD, Vivozon Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: VVZ149-POP-P3-K301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes