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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)
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
Details
| Lead sponsor | Depomed |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2015-01 |
| Completion | 2016-02 |
Conditions
- Migraine
Interventions
- Diclofenac Potassium for Oral Solution
Primary outcomes
- Pharmacokinetics Outcome (1 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• Cmax: maximum concentration (ng/mL) - Pharmacokinetics Outcome (2 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• tmax: time to maximum concentration (min) - Pharmacokinetics Outcome (3 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min) - Pharmacokinetics Outcome (4 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• t1/2: terminal elimination half-life (min) - Pharmacokinetics Outcome (5 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min\*ng/mL) - Pharmacokinetics Outcome (6 of 6) — 6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min\*ng/mL)
Countries
United States