ClinicalTrials.gg
CompletedNCT07821307Updated Sep 15, 2026

Opiranserin Injections PCA Regimens for Postoperative Pain

A Phase 2 interventional study of VVZ-149 Injections and VVZ-149 Injections in Pain, Postoperative / Acute Pain, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2025, registered Sep 2026).

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Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies testing GlyT2/5HT2A Antagonist VVZ-149 in Pain, Postoperative — none open to participants now, none under way, none of them phase 3. GlyT2/5HT2A Antagonist VVZ-149 · Pain, Postoperative.

Enrollment
5th of 10
66 · median 63
Started
2025
the only one that year
Phase 2
7 of 10
none open now
Registered
10th of 10
by date
Lead sponsor
1 of 10
Samsung Medical Center

Among the 10 studies testing GlyT2/5HT2A Antagonist VVZ-149 in Pain, Postoperative, this one is the 5th largest by enrollment, is the only one that started in 2025, is one of 7 in phase 2, and was the 10th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

None of the 10 studies testing GlyT2/5HT2A Antagonist VVZ-149 in Pain, Postoperative is open now. The open studies under Pain, Postoperative, anywhere →

Where they have run

About GlyT2/5HT2A Antagonist VVZ-149

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 19 Years to 75 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies testing GlyT2/5HT2A Antagonist VVZ-149 in Pain, Postoperative as a file.
02

Study 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.

03

Conditions studied

  • Pain, Postoperative / Acute Pain

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04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must have the ability to voluntarily provide written , 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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    VVZ-149 Injections PCA

    Drug: VVZ-149 Injections

  • Active comparator
    VVZ-149 Injections + fentanyl PCA

    Drug: VVZ-149 Injections · Drug: Fentanyl

Interventions

  • 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 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)

    Also known as: opiranserin Injections

  • 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)

06

What researchers measure

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.

    Time frame: 0-8 hours post-emergence

Secondary outcomes

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

    The total number of patient-controlled analgesia (PCA) requests and consumption from Time 0 to 12 hours was compared between the two groups.

    Time frame: 0-12 hours post-emergence

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

    Total amount of PCA and rescue medication consumption from Time 0 to Time 24 hours was compared between the two groups.

    Time frame: 0-12 hours post-emergence

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2025 to primary completion in Dec 2025, 4 months.

Of 90 non-industry phase 2 interventional studies under Pain, Postoperative, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's 4 months is below that.

Counting every sponsor, half of 139 studies reached it within 12 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartActual
Jul 22, 2025
Primary completionActual
Dec 16, 2025
CompletionActual
Jan 9, 2026
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07821307
Collaborators
Vivozon, Inc.
Responsible party
jeayoun Kim (Clinical Assistant Professor, Samsung Medical Center) — Principal investigator
First posted
Sep 15, 2026
Start date
Jul 22, 2025
Primary completion
Dec 16, 2025
Completion
Jan 9, 2026
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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