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

VVZ149-POP-P3-K301

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.

2021-07-19

2022-11-03

2022-11-22

Completed

Early phase I

285

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 285, 'type': 'ACTUAL'}}

2023-03-10