Trial Outcomes & Findings for Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery (NCT NCT05315479)
NCT ID: NCT05315479
Last Updated: 2023-09-13
Results Overview
Number of study subjects who experienced an AE
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Through study completion, approximately 28 Days
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
N1539
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Baseline characteristics by cohort
| Measure |
N1539
n=19 Participants
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 28 DaysNumber of study subjects who experienced an AE
Outcome measures
| Measure |
N1539
n=19 Participants
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily
|
|---|---|
|
Number of Subjects Experiencing an AE
|
3 Participants
|
Adverse Events
N1539
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N1539
n=19 participants at risk
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • 28 Days following study dosing
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19 • Number of events 1 • 28 Days following study dosing
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • 28 Days following study dosing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Number of events 1 • 28 Days following study dosing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER