MedTrace Logo

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

NCT02287376 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-07-25

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Diclofenac Potassium for Oral Solution

NSAID

Sponsors & Collaborators

  • Depomed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287376 on ClinicalTrials.gov