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

Sponsor
Vivozon Pharmaceutical Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05764525
Collaborator
(none)
285
Enrollment
5
Locations
2
Arms
16.1
Actual Duration (Months)
57
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: VVZ-149 Injections
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 19, 2021
Actual Primary Completion Date :
Nov 3, 2022
Actual Study Completion Date :
Nov 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: VVZ-149 Injections

Drug: VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
Other Names:
  • Opiranserin Injections

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    IV infusion of 0 mg of VVZ-149

    Outcome Measures

    Primary Outcome Measures

    1. Time-weighted Sum of Pain Intensity Differences for 12 hours post-dose (SPID 12) [0-12 hours post-dose]

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

    Secondary Outcome Measures

    1. Total number of patient-controlled analgesia (PCA) requests for 12 hours post-dose [0-12 hours post-dose]

    2. Total amount of PCA and rescue medication consumption for 12 hours post-dose [0-12 hours post-dose]

    3. 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]

    4. Time-weighted SPID for 24 hours post-dose (SPID 24) [0-24 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of
    2 Korea University Anam Hospital Seoul Korea, Republic of
    3 Samsung Medical Center Seoul Korea, Republic of
    4 Seoul National University Bundang Hospital Seoul Korea, Republic of
    5 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Vivozon Pharmaceutical Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vivozon Pharmaceutical Inc.
    ClinicalTrials.gov Identifier:
    NCT05764525
    Other Study ID Numbers:
    • VVZ149-POP-P3-K301
    First Posted:
    Mar 10, 2023
    Last Update Posted:
    Mar 10, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acute Pain

    Study Results

    No Results Posted as of Mar 10, 2023