Esomeprazole for treatment of GERD in pediatric patients

Study identifier:D9614C00097

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.

Medical condition

Gastroesophageal reflux disease (GERD)

Phase

Phase 4

Healthy volunteers

No

Study drug

Esomeprazole (Nexium)

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

1 Years - 11 Years

Date

Study Start Date: 01 Oct 2004
Primary Completion Date: -
Study Completion Date: 01 Oct 2005

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria