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

Vivozon

Status and phase

Completed

Phase 3

Conditions

Pain, Postoperative

Acute Pain

Treatments

Drug: VVZ-149 Injections

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05764525

VVZ149-POP-P3-K301

Details and patient eligibility

About

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.

Enrollment

285 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)