drugset / Trial / NCT02287376
Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 50 mg | Oral |