Opiranserin Injections PCA Regimens for Postoperative Pain

NCT07821307 | Completed Phase 2 FDA Drug

• 1 other identifier: VVZ149-PCA-K203
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase 2 study is to evaluate the efficacy and safety of PCA regimen of opiranserin (VVZ-149) injections in patients undergoing laparoscopic colectomy.

Conditions

Pain, Postoperative / Acute Pain

Outcome Measures

Primary Outcomes (1)

• Area under the pain intensity-time curve over 8 hours (AUC 8)

  Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). The area under the curve of the pain intensity over time graph from 0 to 8 hours will be calculated using pain intensity measured at scheduled time points and pre-rescue medication time points, as well as imputed values.

  0-8 hours post-emergence

Secondary Outcomes (2)

• Number of PCA and rescue medication use and requests, and consumption measured at 2 hours for 12 hours post-emergence

  0-12 hours post-emergence

• Number of PCA and rescue medication use and requests, and consumption measured at 6 hours for 24 hours post-emergence

  0-12 hours post-emergence

Study Arms (2)

VVZ-149 Injections PCA

EXPERIMENTAL

Drug: VVZ-149 Injections

VVZ-149 Injections + fentanyl PCA

ACTIVE COMPARATOR

Drug: VVZ-149 Injections; Drug: Fentanyl

Interventions

VVZ-149 Injections DRUG

VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections will be administered via PCA (VVZ-149 10 mg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)

Also known as: opiranserin Injections

VVZ-149 Injections PCA

Fentanyl DRUG

VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections + fentanyl will be administered (VVZ-149 injections 10 mg + fentanyl 4 μg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)

VVZ-149 Injections + fentanyl PCA

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have the ability to voluntarily provide written informed consent, understand study
• Men and women subjects aged ≥19 years and \<75 years
• Female subjects who are not pregnant or breastfeeding
• Subjects must be undergoing a planned first laparoscopic colectomy
• Subjects classified in American Society Anesthesiologist (ASA) risk class of I or II

You may not qualify if:

• Subjects undergoing emergency or unplanned surgery
• Subjects who had a previous laparoscopic colectomy or resection procedure
• Subjects with pre-existing conditions causing preoperative pain around 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Vivozon, Inc.: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: July 22, 2025
• Primary Completion: December 16, 2025
• Study Completion: January 9, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)