Who is sponsoring NCT02424578?

NCT02424578 is sponsored by Iroko Pharmaceuticals, LLC.

What condition does NCT02424578 study?

NCT02424578 studies Pain, Postoperative.

What drugs are being tested in NCT02424578?

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

What is the status of NCT02424578?

NCT02424578 is currently COMPLETED.

Last reviewed 2017-06-14 · How we verify

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

NCT02424578 Phase 2 COMPLETED Results posted

The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac 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	2015-05
Completion	2016-04-19

Conditions

Pain, Postoperative

Interventions

Diclofenac Capsules low dose
Diclofenac Capsules high dose

Primary outcomes

Plasma Concentration of Diclofenac — 0-6 hours after first dose of diclofenac
The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.

Countries

United States