CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
Esomeprazoledrug
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.

Search/NCT00427635
NCT00427635Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jan 29, 2007·Updated Dec 20, 2010

In Brief

A Phase 3 clinical trial evaluating Esomeprazole for GERD. Completed, enrolled 32 participants across 3 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGERD
CountriesAustralia, Germany, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2007
Enrollment StartOct 1, 2006
Study CompletionApr 1, 2009
TodayJul 2, 2026
Posted 19.4 years ago

Interventions

Esomeprazoledrug