Post Operative Pain
Conditions
Keywords
meloxicam, pediatric
Brief summary
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.
Interventions
DRUGN1539
Once daily
Sponsors
Baudax Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 2 to \<17 years of age before dosing on Day 1 * Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia * Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential * Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent
Exclusion criteria
* Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539 * Have a known bleeding disorder that may be worsened with the administration of an NSAID * Be undergoing cardiothoracic surgery * Has used meloxicam within 7 days before the surgical procedure on Day 1 * Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing an AE | Through study completion, approximately 28 Days | Number of study subjects who experienced an AE |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N1539 N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
N1539: Once daily | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | N1539 |
|---|---|
| Age, Categorical <=18 years | 19 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 16 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 3 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Number of Subjects Experiencing an AE
Number of study subjects who experienced an AE
Time frame: Through study completion, approximately 28 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N1539 | Number of Subjects Experiencing an AE | 3 Participants |