Status:
TERMINATED
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Lead Sponsor:
Baudax Bio
Conditions:
Post Operative Pain
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05315479
Start Date
February 24 2022
End Date
July 7 2022
Last Update
September 13 2023
Active Locations (3)
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1
Research Center
Sheffield, Alabama, United States, 35660
2
Research Center
Bakersfield, California, United States, 93301
3
Research Center
Salt Lake City, Utah, United States, 84107