Who is sponsoring NCT02633969?

NCT02633969 is sponsored by Iroko Pharmaceuticals, LLC.

What condition does NCT02633969 study?

NCT02633969 studies Pain, Postoperative.

What drugs are being tested in NCT02633969?

Interventions: Indomethacin Capsules low dose, Indomethacin Capsules high dose.

What is the status of NCT02633969?

NCT02633969 is currently COMPLETED.

Last reviewed 2018-01-24 · How we verify

A Phase IIA, Open-label, Safety and Pharmacokinetic Study of Indomethacin Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery

NCT02633969 Phase 2 COMPLETED

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of indomethacin capsules low dose and high dose in children ages 6 to \<17 years experiencing mild to moderate acute postoperative pain.

Details

Lead sponsor	Iroko Pharmaceuticals, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	30
Start date	2015-12
Completion	2017-01

Conditions

Pain, Postoperative

Interventions

Indomethacin Capsules low dose
Indomethacin Capsules high dose

Primary outcomes

Plasma Concentrations of indomethacin — 0-12 hours after first dose of indomethacin
The estimated typical value for clearance (tvCL) following a single indomethacin dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.

Countries

United States