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

Phase 3

Completed

• Conditions: Acute Pain; Pain, Postoperative
• Interventions: Drug: Placebo; Drug: VVZ-149 Injections

• Registration Number: NCT05764525
• Lead Sponsor: Vivozon Pharmaceutical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-19
• Primary Completion: 2022-11-03
• Study Completion: 2022-11-22
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Results First Submitted: 2025-01-02
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Results First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
VVZ-149 Injections	VVZ-149 Injections	-

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)	0-12 hours post-dose	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

Secondary Outcome Measures

Name	Time	Method
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose	0-12 hours post-dose	Total number of patient-controlled analgesia (PCA) requests from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose	0-12 hours post-dose	Total amount of PCA and rescue medication consumption from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.

Trial Locations

Locations (5)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of