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Completed

NCT Number: NCT05764525

Efficacy and Safety of VVZ-149 Injections in Patients Undergoing 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.

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Key information

Conditions

Pain, Postoperative Acute Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VVZ-149 Injections

Drug

IV infusion of 1000 mg of VVZ-149

Other names: Opiranserin Injections

Placebo

Drug

IV infusion of 0 mg of VVZ-149

Primary outcomes

  1. Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)

    Time frame: 0-12 hours post-dose

    Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Time-weighted Sum of Pain Intensity Difference (PID) for 12 hours post-dose (SPID 12) was estimated using the linear trapezoidal rule (L x Hour) with the PI scores assigned from Time 0 to Time 12 hours post-dose using the following formula. The theoretical SPID 12 ranges from 0 to 120. A higher value of SPID indicates greater pain relief.

    SPID 12 = S [T(i)-T(i-1)] × [PID(i)+PID(i-1)]/2, when PID(i) =Predose PI-PI at Time i

Secondary outcomes

  1. Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose

    Time frame: 0-12 hours post-dose

    Total number of patient-controlled analgesia (PCA) requests from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.

  2. Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose

    Time frame: 0-12 hours post-dose

    Total amount of PCA and rescue medication consumption from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.

Sponsors and collaborators

Lead sponsor

Vivozon Pharmaceutical Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2023
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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