Conditions: Migraine
Keywords: Migraine with and without aura
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Diclofenac Potassium for Oral Solution 50 mg

Interventions: intervention 1: Diclofenac Potassium for Oral Solution
Intervention descriptions: intervention 1: NSAID

Protocol document: