Pain, PostoperativePhase 3NCT05764525
Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy
A Phase 3 study testing VVZ-149 Injections in people with Pain, Postoperative and Acute Pain, run by Vivozon Pharmaceutical Inc. at 5 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Acute Pain
- What is being tested?
- VVZ-149 Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 19 Jul 2021to 22 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official 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
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.
- Conditions
- Pain, Postoperative, Acute Pain
- Being tested
- VVZ-149 Injections, Placebo
- Medical subject headings
- Pain, Postoperative, Acute Pain
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
IV infusion of 1000 mg of VVZ-149
PlaceboDrug
IV infusion of 0 mg of VVZ-149
| Study group | Role | What they receive |
|---|---|---|
| VVZ-149 Injections | Experimental | Not described Receives: Drug: VVZ-149 Injections |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
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
Measured: 0-12 hours post-dose
Secondary outcomes (2)
Total Number of Patient-controlled Analgesia (PCA) Requests for 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.
Measured: 0-12 hours post-dose
Total Amount of PCA and Rescue Medication Consumption for 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.
Measured: 0-12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start19 Jul 2021
- Primary completion3 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivozon Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doo Lee, PhD, Study chair, Vivozon Pharmaceutical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764525
- Sponsor's protocol ID
- VVZ149-POP-P3-K301
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2023
- Last updated
- 20 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee HJ, Sim JY, Song I, Nedeljkovic SS, Kim DK, Oh AY, Yoon SZ, Moon YJ, Park MH, Park I, Kim J, Lee SR, Cho S, Bahk JH. Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. J Clin Anesth. 2025 Feb;101:111729. doi: 10.1016/j.jclinane.2024.111729. Epub 2024 Dec 19.
PubMed 39705738
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05764525
- Acronym / sponsor ID
- VVZ149-POP-P3-K301
- Conditions
- Pain, Postoperative, Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Vivozon Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 20 Feb 2025
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 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following 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 | Experimental | Drug: VVZ-149 Injections |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 InjectionsIV infusion of 1000 mg of VVZ-149 | Drug | VVZ-149 Injections |
| PlaceboIV infusion of 0 mg of VVZ-149 | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
Time frame: 0-12 hours post-dose
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Time frame: 0-12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39705738Lee HJ, Sim JY, Song I, Nedeljkovic SS, Kim DK, Oh AY, Yoon SZ, Moon YJ, Park MH, Park I, Kim J, Lee SR, Cho S, Bahk JH. Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy. J Clin Anesth. 2025 Feb;101:111729. doi: 10.1016/j.jclinane.2024.111729. Epub 2024 Dec 19.
- Individual participant dataSharing planned: Undecided
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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.
Doo Lee, PhD study chair
Vivozon Pharmaceutical Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VVZ-149 Injections in people with Pain, Postoperative and Acute Pain, run by Vivozon Pharmaceutical Inc. at 5 sites 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 7 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12) (time frame: 0-12 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764525, which also lists 1 linked publication.
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 20 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.