N1539 for Postoperative Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Postoperative PainN1539 - Drug
Eligibility
2 - 16
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Postoperative Pain

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: Through study completion, approximately 28 Days

24 hours
Assessment of Pharmacokinetics: Area Under the Curve from Time Zero to Infinity (AUC0-∞)
Assessment of Pharmacokinetics: Clearance (CL)
Assessment of Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Assessment of Pharmacokinetics: Minimum Plasma Concentration (Cmin)
Assessment of Pharmacokinetics: Terminal Elimination Half-Life (t1/2)
Assessment of Pharmacokinetics: Volume of Distribution (V)
7 Days
Assessment of Surgical Wound Healing
Day 28
Incidence of AEs and SAEs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

N1539 30 mg
20%Nausea
8%Headache
8%Pruritus
4%Constipation
3%Flushing
3%Vomiting
3%Somnolence
3%Dizziness
2%Cellulitis
2%Decreased appetite
2%Skin abrasion
2%Blister
2%Diarrhoea
2%Oedema peripheral
2%Pruritus generalised
2%Hyperhidrosis
1%Pollakiuria
1%Injection site pain
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02675907) in the N1539 30 mg ARM group. Side effects include: Nausea with 20%, Headache with 8%, Pruritus with 8%, Constipation with 4%, Flushing with 3%.

Trial Design

1 Treatment Group

N1539
1 of 1

Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: N1539 · No Placebo Group · Phase 4

N1539
Drug
Experimental Group · 1 Intervention: N1539 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N1539
2016
Completed Phase 3
~2170

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, approximately 28 days

Who is running the clinical trial?

Baudax BioLead Sponsor
10 Previous Clinical Trials
1,838 Total Patients Enrolled

Eligibility Criteria

Age 2 - 16 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female 2 to <17 years of age before dosing on Day 1.
You are eligible for elective surgery that will be performed under appropriate anesthesia.
You are willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent.