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

Phase 4

Terminated

• Conditions: Post Operative Pain
• Interventions: Drug: N1539

• Registration Number: NCT05315479
• Lead Sponsor: Baudax Bio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-07
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Results First Submitted: 2023-07-28
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N1539	N1539	N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H

Primary Outcome Measures

Name	Time	Method
Number of Subjects Experiencing an AE	Through study completion, approximately 28 Days	Number of study subjects who experienced an AE

Trial Locations

Locations (1)

Research Center; 🇺🇸 Salt Lake City, Utah, United States