Pain, Postoperative / Acute PainPhase 2NCT07821307
Opiranserin Injections PCA Regimens for Postoperative Pain
A Phase 2 study testing VVZ-149 Injections and Fentanyl in people with Pain, Postoperative / Acute Pain, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Pain, Postoperative / Acute Pain
- What is being tested?
- VVZ-149 Injections and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2025to 9 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel Group, Exploratory Study to Evaluate the Efficacy and Safety of PCA Regimen of VVZ-149 Injections for the Treatment of Post-Operative Pain
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
- Being tested
- VVZ-149 Injections, Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVZ-149 InjectionsDrug
Also called 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 will be administered via PCA (VVZ-149 10 mg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)
VVZ-149 InjectionsDrug
Also called 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)
FentanylDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 Injections PCA | Experimental | Not described Receives: Drug: VVZ-149 Injections |
| VVZ-149 Injections + fentanyl PCA | Active comparator | Not described Receives: Drug: VVZ-149 Injections; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The total number of patient-controlled analgesia (PCA) requests and consumption from Time 0 to 12 hours was compared between the two groups.
Measured: 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
Total amount of PCA and rescue medication consumption from Time 0 to Time 24 hours was compared between the two groups.
Measured: 0-12 hours post-emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start22 Jul 2025
- Primary completion16 Dec 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Postoperative / Acute PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vivozon, Inc.
- Responsible party
- Principal investigator, jeayoun Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821307
- Sponsor's protocol ID
- VVZ149-PCA-K203
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Parallel Group, Exploratory Study to Evaluate the Efficacy and Safety of PCA Regimen of VVZ-149 Injections for the Treatment of Post-Operative Pain
- ClinicalTrials.gov ID
- NCT07821307
- Acronym / sponsor ID
- VVZ149-PCA-K203
- Conditions
- Pain, Postoperative / Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Vivozon, Inc.
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VVZ-149 Injections PCA | Experimental | Drug: VVZ-149 Injections |
| VVZ-149 Injections + fentanyl PCA | Active comparator | Drug: VVZ-149 Injections, Drug: Fentanyl |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVZ-149 InjectionsAlso: opiranserin InjectionsVVZ-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) | Drug | VVZ-149 Injections PCA |
| VVZ-149 InjectionsAlso: opiranserin InjectionsVVZ-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) | Drug | VVZ-149 Injections + fentanyl PCA |
| FentanylVVZ-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) | Drug | VVZ-149 Injections + fentanyl PCA |
Primary outcome
Area under the pain intensity-time curve over 8 hours (AUC 8)
Time frame: 0-8 hours post-emergence
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.
2 secondary outcomes
Number of PCA and rescue medication use and requests, and consumption measured at 2 hours for 12 hours post-emergence
Time frame: 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
Time frame: 0-12 hours post-emergence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VVZ-149 Injections and Fentanyl in people with Pain, Postoperative / Acute Pain, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the pain intensity-time curve over 8 hours (AUC 8) (time frame: 0-8 hours post-emergence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.