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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764525
• Other study ID #: VVZ149-POP-P3-K301
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: February 2023
• Source: Vivozon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: November 22, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Intervention

Drug:
• VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
• Placebo
IV infusion of 0 mg of VVZ-149

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Vivozon Pharmaceutical Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of patient-controlled analgesia (PCA) requests for 12 hours post-dose		0-12 hours post-dose
Secondary	Total amount of PCA and rescue medication consumption for 12 hours post-dose		0-12 hours post-dose
Secondary	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
Secondary	Time-weighted SPID for 24 hours post-dose (SPID 24)		0-24 hours post-dose