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N1539 for Postoperative Pain

Phase 4
Waitlist Available
Research Sponsored by Baudax Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 28 days
Awards & highlights

Study Summary

This trial is testing the safety and how well a drug works in children after surgery.

Eligible Conditions
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects Experiencing an AE

Side effects data

From 2018 Phase 3 trial • 57 Patients • NCT03323385
33%
Nausea
19%
Vomiting
7%
Urinary retention
4%
Incision site cellulitis
4%
Ileus
4%
Constipation
4%
Wound dehiscence
100%
80%
60%
40%
20%
0%
Study treatment Arm
N1539 30 mg
IV Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: N1539Experimental Treatment1 Intervention
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N1539
2016
Completed Phase 3
~2170

Find a Location

Who is running the clinical trial?

Baudax BioLead Sponsor
10 Previous Clinical Trials
1,840 Total Patients Enrolled

Media Library

N1539 Clinical Trial Eligibility Overview. Trial Name: NCT05315479 — Phase 4
Postoperative Pain Research Study Groups: N1539
Postoperative Pain Clinical Trial 2023: N1539 Highlights & Side Effects. Trial Name: NCT05315479 — Phase 4
N1539 2023 Treatment Timeline for Medical Study. Trial Name: NCT05315479 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is the use of N1539 for affected individuals?

"The drug N1539 was given a score of 3 on our 1-3 scale as it is approved for use in Phase 4 clinical trials, thus implying that there is significant evidence backing its safety."

Answered by AI

Who meets the requisite eligibility criteria for enrollment in this trial?

"Eligibility for this trial requires that the patient has postoperative pain and falls within the age range of 2 to 16 years old. 90 participants are desired in total."

Answered by AI

Is the minimum age requirement for participation in this study more than 25 years of age?

"The parameters for participation in this trial stipulate that applicants must be aged two to sixteen. Furthermore, there are 69 clinical trials targeting minors and 369 specifically focusing on elderly individuals."

Answered by AI

Is this research effort presently recruiting participants?

"The information found on clinicaltrials.gov discloses that this medical trial is actively seeking applicants, with the listing being first published on February 24th 2022 and most recently updated May 26th of the same year."

Answered by AI

How many individuals are currently in the sample cohort of this research?

"Affirmative. Clinicaltrials.gov data shows that the trial, first registered on February 24th 2022, is actively seeking applicants. At this time, 90 individuals need to be recruited from 3 different medical facilities."

Answered by AI
~6 spots leftby Mar 2025