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

Baudax Bio

Status and phase: Terminated; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: N1539

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315479

BDX-20-002

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

N1539

Experimental group

Description:

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

Treatment:

Drug: N1539