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

• Status: Completed
• Trial end date: 2022-11-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivozon Pharmaceutical Inc.

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)