Pharmacokinetic study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

Study identifier:D9614C00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

Medical condition

endoscopically-proven GERD

Phase

Phase 1

Healthy volunteers

No

Study drug

esomeprazole magnesium

Sex

All

Actual Enrollment

40

Study type

Interventional

Age

1 Years - 11 Years

Date

Study Start Date: 01 Aug 2006
Primary Completion Date: 01 May 2008
Study Completion Date: 01 May 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria