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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2022-07-07

Brief Summary

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

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Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N1539

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

Group Type EXPERIMENTAL

N1539

Intervention Type DRUG

Once daily

Interventions

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N1539

Once daily

Intervention Type DRUG

Other Intervention Names

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Meloxicam IV

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No