Efficacy and Safety of VVZ-149 Injections in Patients Undergoing 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

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)	Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Time-weighted Sum of Pain Intensity Difference (PID) for 12 hours post-dose (SPID 12) was estimated using the linear trapezoidal rule (L x Hour) with the PI scores assigned from Time 0 to Time 12 hours post-dose using the following formula. The theoretical SPID 12 ranges from 0 to 120. A higher value of SPID indicates greater pain relief. SPID 12 = S [T(i)-T(i-1)] × [PID(i)+PID(i-1)]/2, when PID(i) =Predose PI-PI at Time i	0-12 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose	Total number of patient-controlled analgesia (PCA) requests from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.	0-12 hours post-dose
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose	Total amount of PCA and rescue medication consumption from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.	0-12 hours post-dose

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lee HJ, Sim JY, Song I, Nedeljkovic SS, Kim DK, Oh AY, Yoon SZ, Moon YJ, Park MH, Park I, Kim J, Lee SR, Cho S, Bahk JH. Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. J Clin Anesth. 2025 Feb;101:111729. doi: 10.1016/j.jclinane.2024.111729. Epub 2024 Dec 19.

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 (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; 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