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NCT05315479 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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