Clinical trial NCT05764525: Efficacy and Safety of VVZ-149 Injections in Patients Undergoing 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Acute Pain
Lead sponsor: Vivozon, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
timeFrame: 0-12 hours post-dose
Secondary outcomes:
measure: Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
timeFrame: 0-12 hours post-dose
measure: Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
timeFrame: 0-12 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Vivozon Pharmaceutical Inc.
name: Doo Lee, PhD
role: STUDY_CHAIR
References:
citation: Lee HJ, Sim JY, Song I, Nedeljkovic SS, Kim DK, Oh AY, Yoon SZ, Moon YJ, Park MH, Park I, Kim J, Lee SR, Cho S, Bahk JH. Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. J Clin Anesth. 2025 Feb;101:111729. doi: 10.1016/j.jclinane.2024.111729. Epub 2024 Dec 19.