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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVZ-149 Injections | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVZ-149 Injections | Drug | IV infusion of 1000 mg of VVZ-149 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-12 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-12 hours post-dose |
| Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doo Lee, PhD | Vivozon Pharmaceutical Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | ||||
| Korea University Anam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39705738 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VVZ-149 Injections | IV infusion of 1000 mg of VVZ-149 |
| FG001 | Placebo | IV infusion of 0 mg of VVZ-149 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VVZ-149 Injections | IV infusion of 1000 mg of VVZ-149 |
| BG001 | Placebo | IV infusion of 0 mg of VVZ-149 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | mITT | Posted | Least Squares Mean | Standard Error | score on a scale*hours | 0-12 hours post-dose |
|
21 days (+7d)
Following laparoscopic colectomy, adverse events were monitored continuously during Time 0 to Time 48 hours and a safety follow-up assessment was performed between Days 21 and 28.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VVZ-149 Injections | IV infusion of 1000 mg of VVZ-149 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Vivozon, Inc. | 609 269 9140 | adminus@vivozon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2023 | Jan 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo | Drug | IV infusion of 0 mg of VVZ-149 |
|
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. |
| 0-12 hours post-dose |
| Seoul |
| South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Physician Decision |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 |
| Placebo |
IV infusion of 0 mg of VVZ-149 |
|
|
|
| Secondary | 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. | mITT | Posted | Mean | Standard Deviation | requests | 0-12 hours post-dose |
|
|
|
| Secondary | 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. | mITT | Posted | Mean | Standard Deviation | mg | 0-12 hours post-dose |
|
|
|
| 141 |
| 0 |
| 141 |
| 101 |
| 141 |
| EG001 | Placebo | IV infusion of 0 mg of VVZ-149 | 0 | 143 | 0 | 143 | 98 | 143 |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Time 8-10 Hour |
|
| Time 6-8 Hour |
|
| Time 8-10 Hour |
|