MedTrace Logo

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

NCT05315479 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-09-13

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Post Operative Pain

Interventions

DRUG

N1539

Once daily

Sponsors & Collaborators

  • Baudax Bio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2022-07-07
Completion
2022-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315479 on ClinicalTrials.gov