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

Study Overview
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Acute Pain

Intervention / Treatment
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* Drug: VVZ-149 Injections
* Drug: Placebo


Participation Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVZ-149 Injections<br> | Drug: VVZ-149 Injections<br>* IV infusion of 1000 mg of VVZ-149<br>* Other names: Opiranserin Injections;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* IV infusion of 0 mg of VVZ-149<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of Pain Intensity Differences for 12 hours post-dose (SPID 12) | Using Numeric Pain Rating Scale (NRS, 0-10) | 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 |  | 0-12 hours post-dose | 
| Total amount of PCA and rescue medication consumption for 12 hours post-dose |  | 0-12 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 |  | 0-6 hours post-dose | 
| Time-weighted SPID for 24 hours post-dose (SPID 24) |  | 0-24 hours post-dose |