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

Primary Purpose

Post Operative Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
N1539
Sponsored by
Baudax Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring meloxicam, pediatric

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Research Center
  • Research Center
  • Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

N1539

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Subjects Experiencing an AE
Number of study subjects who experienced an AE

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
August 22, 2023
Sponsor
Baudax Bio
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1. Study Identification

Unique Protocol Identification Number
NCT05315479
Brief Title
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Anjeso (N1539) NDA Withdrawn
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
July 7, 2022 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baudax Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
meloxicam, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N1539
Arm Type
Experimental
Arm Description
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
Intervention Type
Drug
Intervention Name(s)
N1539
Other Intervention Name(s)
Meloxicam IV
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Number of Subjects Experiencing an AE
Description
Number of study subjects who experienced an AE
Time Frame
Through study completion, approximately 28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Center
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Research Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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