NCT02287376

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

A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Cambia® (Diclofenac Potassium for Oral Solution) for the Acute Treatment of Migraine Attacks With or Without Aura in Pediatric Subjects (Ages 12-17 Years)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Depomed · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Diclofenac Potassium for Oral Solution	NSAID

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-11-10
• Last updated: 2017-07-25
• Results posted: 2017-07-25

Locations

2 sites across 1 country: United States