Study Stopped
Anjeso (N1539) NDA Withdrawn
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
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
1 other identifier
interventional
19
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2022
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2022
CompletedFirst Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2022
CompletedResults Posted
Study results publicly available
September 13, 2023
CompletedSeptember 13, 2023
August 1, 2023
4 months
March 15, 2022
July 28, 2023
August 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects Experiencing an AE
Number of study subjects who experienced an AE
Through study completion, approximately 28 Days
Study Arms (1)
N1539
EXPERIMENTALN1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baudax Biolead
Study Sites (3)
Research Center
Sheffield, Alabama, 35660, United States
Research Center
Bakersfield, California, 93301, United States
Research Center
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Development
- Organization
- Baudax Bio
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 7, 2022
Study Start
February 24, 2022
Primary Completion
July 7, 2022
Study Completion
July 7, 2022
Last Updated
September 13, 2023
Results First Posted
September 13, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share