At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
Diclofenac Potassium for Oral Solutiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Diclofenac Potassium for Oral Solution for Migraine. Completed, enrolled 25 participants across 2 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedNov 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago
Interventions
Diclofenac Potassium for Oral Solutiondrug
NSAID