Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2022-11-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VVZ-149 Injections

Group Type EXPERIMENTAL

VVZ-149 Injections

Intervention Type DRUG

IV infusion of 1000 mg of VVZ-149

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion of 0 mg of VVZ-149

Interventions

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VVZ-149 Injections

IV infusion of 1000 mg of VVZ-149

Intervention Type DRUG

Placebo

IV infusion of 0 mg of VVZ-149

Intervention Type DRUG

Other Intervention Names

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Opiranserin Injections

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No