NCT05764525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 28, 2023

Results QC Date

January 2, 2025

Last Update Submit

February 18, 2025

Conditions

Pain, PostoperativeAcute Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

VVZ-149 Injections

EXPERIMENTAL
Drug: VVZ-149 Injections

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VVZ-149 InjectionsDRUG

IV infusion of 1000 mg of VVZ-149

Also known as: Opiranserin Injections
VVZ-149 Injections
PlaceboDRUG

IV infusion of 0 mg of VVZ-149

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 39705738RESULT

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Chief Medical Officer
Organization
Vivozon, Inc.
adminus@vivozon.com
609 269 9140

Study Officials

  • Doo Lee, PhD

    Vivozon Pharmaceutical Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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

February 28, 2023

First Posted

March 10, 2023

Study Start

July 19, 2021

Primary Completion

November 3, 2022

Study Completion

November 22, 2022

Last Updated

February 20, 2025

Results First Posted

February 20, 2025

Record last verified: 2025-02

Locations

KR(5)