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

Primary Purpose

Pain, Postoperative, Acute Pain

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VVZ-149 Injections
Placebo
Sponsored by
Vivozon Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VVZ-149 Injections

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total number of patient-controlled analgesia (PCA) requests for 12 hours post-dose
Total amount of PCA and rescue medication consumption for 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
Time-weighted SPID for 24 hours post-dose (SPID 24)

Full Information

First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Vivozon Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05764525
Brief Title
Phase 3 Efficacy and Safety of VVZ-149 Injections for Postoperative Pain Following Laparoscopic Colectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivozon Pharmaceutical Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VVZ-149 Injections
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VVZ-149 Injections
Other Intervention Name(s)
Opiranserin Injections
Intervention Description
IV infusion of 1000 mg of VVZ-149
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion of 0 mg of VVZ-149
Primary Outcome Measure Information:
Title
Time-weighted Sum of Pain Intensity Differences for 12 hours post-dose (SPID 12)
Description
Using Numeric Pain Rating Scale (NRS, 0-10)
Time Frame
0-12 hours post-dose
Secondary Outcome Measure Information:
Title
Total number of patient-controlled analgesia (PCA) requests for 12 hours post-dose
Time Frame
0-12 hours post-dose
Title
Total amount of PCA and rescue medication consumption for 12 hours post-dose
Time Frame
0-12 hours post-dose
Title
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
Time Frame
0-6 hours post-dose
Title
Time-weighted SPID for 24 hours post-dose (SPID 24)
Time Frame
0-24 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo Lee, PhD
Organizational Affiliation
Vivozon Pharmaceutical Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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