Efficacy and safety of esomeprazole once daily for the treatment of GERD in neonatal patients

Study identifier:D9614C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, double-blind, placebo controlled, study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age

Medical condition

GERD

Phase

Phase 3

Healthy volunteers

No

Study drug

Esomeprazole

Sex

All

Actual Enrollment

32

Study type

Interventional

Age

N/A - 1 Months

Date

Study Start Date: 01 Oct 2006
Primary Completion Date: -
Study Completion Date: 01 Apr 2009

Study design

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

Verification:

Verified 01 Dec 2010 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria