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Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

NCT00427635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-12-20

Study results available
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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.

Conditions

  • GERD

Interventions

DRUG

Esomeprazole

Sponsors & Collaborators

Principal Investigators

  • Marta Illueca, MD · AstraZeneca

  • Per Lundborg, MD · AstraZeneca

  • Kathryn Collison, MPH, MT(ASCP) · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Completion
2009-04-30

Countries

  • Australia
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00427635 on ClinicalTrials.gov