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

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

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.

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)