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

August 22, 2023 updated by: Baudax Bio

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Research Center
    • California
      • Bakersfield, California, United States, 93301
        • Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N1539
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
Drug: N1539
Once daily
Other Names:
  • Meloxicam IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Experiencing an AE
Time Frame: Through study completion, approximately 28 Days
Number of study subjects who experienced an AE
Through study completion, approximately 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baudax Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

July 7, 2022

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDX-20-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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