Trial Outcomes & Findings for Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy (NCT NCT05764525)
NCT ID: NCT05764525
Last Updated: 2025-02-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
0-12 hours post-dose
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
|
Placebo
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
143
|
|
Overall Study
Treated
|
141
|
143
|
|
Overall Study
COMPLETED
|
136
|
135
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
|
Placebo
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Overall Study
Inclusion/exclusion criteria not met Inclusion/exclusion criteria not met
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of VVZ-149 Injections in Patients Undergoing Laparoscopic Colectomy
Baseline characteristics by cohort
| Measure |
VVZ-149 Injections
n=141 Participants
IV infusion of 1000 mg of VVZ-149
|
Placebo
n=143 Participants
IV infusion of 0 mg of VVZ-149
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 9.76 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
141 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
141 participants
n=5 Participants
|
143 participants
n=7 Participants
|
284 participants
n=5 Participants
|
|
BMI
|
24.66 kg/m2
STANDARD_DEVIATION 3.044 • n=5 Participants
|
24.21 kg/m2
STANDARD_DEVIATION 2.610 • n=7 Participants
|
24.44 kg/m2
STANDARD_DEVIATION 2.838 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-12 hours post-dosePopulation: mITT
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
Outcome measures
| Measure |
VVZ-149 Injections
n=141 Participants
IV infusion of 1000 mg of VVZ-149
|
Placebo
n=143 Participants
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
|
26.83 score on a scale*hours
Standard Error 1.73
|
19.89 score on a scale*hours
Standard Error 1.72
|
SECONDARY outcome
Timeframe: 0-12 hours post-dosePopulation: mITT
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.
Outcome measures
| Measure |
VVZ-149 Injections
n=141 Participants
IV infusion of 1000 mg of VVZ-149
|
Placebo
n=143 Participants
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
Time 8-10 Hour
|
4.6 requests
Standard Deviation 6.88
|
8.0 requests
Standard Deviation 16.18
|
|
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
Time 4-6 Hour
|
7.0 requests
Standard Deviation 10.24
|
17.6 requests
Standard Deviation 63.54
|
|
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
Time 6-8 Hour
|
5.0 requests
Standard Deviation 5.97
|
10.1 requests
Standard Deviation 19.79
|
SECONDARY outcome
Timeframe: 0-12 hours post-dosePopulation: mITT
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.
Outcome measures
| Measure |
VVZ-149 Injections
n=141 Participants
IV infusion of 1000 mg of VVZ-149
|
Placebo
n=143 Participants
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Time 2-4 Hour
|
38.6 mg
Standard Deviation 28.28
|
47.0 mg
Standard Deviation 32.92
|
|
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Time 4-6 Hour
|
24.0 mg
Standard Deviation 20.45
|
31.9 mg
Standard Deviation 27.00
|
|
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Time 6-8 Hour
|
19.1 mg
Standard Deviation 19.63
|
27.6 mg
Standard Deviation 25.36
|
|
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Time 8-10 Hour
|
17.8 mg
Standard Deviation 19.64
|
24.9 mg
Standard Deviation 24.13
|
Adverse Events
VVZ-149 Injections
Serious events: 0 serious events
Other events: 101 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VVZ-149 Injections
n=141 participants at risk
IV infusion of 1000 mg of VVZ-149
|
Placebo
n=143 participants at risk
IV infusion of 0 mg of VVZ-149
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.0%
48/141 • 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.
|
30.8%
44/143 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
13.5%
19/141 • 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.
|
7.0%
10/143 • 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.
|
|
Gastrointestinal disorders
Haematochezia
|
7.1%
10/141 • 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.
|
6.3%
9/143 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
31.9%
45/141 • 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.
|
28.7%
41/143 • 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.
|
|
Vascular disorders
Hypertension
|
8.5%
12/141 • 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.
|
7.7%
11/143 • 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.
|
|
Vascular disorders
Phlebitis
|
7.1%
10/141 • 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.
|
3.5%
5/143 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
5/141 • 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.
|
8.4%
12/143 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place