Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

Post Operative Pain Clinical Trial

Official title:

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05315479
• Other study ID #: BDX-20-002
• Status: Terminated
• Phase: Phase 4
• Start date: February 24, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: August 2023
• Source: Baudax Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• N1539
Once daily

Locations

Country	Name	City	State
United States	Research Center	Bakersfield	California
United States	Research Center	Salt Lake City	Utah
United States	Research Center	Sheffield	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Baudax Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing an AE	Number of study subjects who experienced an AE	Through study completion, approximately 28 Days