drugset / Trial / NCT02287376

Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds

NCT02287376

Phase 4 Completed 25 enrolled Depomed
NaSingle-groupOpen-labelTreatment

Summary

Study Objectives: 1. The primary objective is to characterize the pharmacokinetics of a single oral administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis of episodic migraine with or without aura. 2. The secondary objectives are to determine: 1. The safety and tolerability of Cambia from a single dose 2. Three-month safety evaluation of Cambia in outpatient usage in this population

Timeline

Start
2015-01
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 50 mg Oral

Indications