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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00427635
First received: January 25, 2007
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
GERD
Drug: Esomeprazole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.


Secondary Outcome Measures:
  • Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.

  • Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes based on 24-hour impedance monitoring data

  • Change From Baseline in Number of Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data

  • Change From Baseline in Number of Weakly Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data

  • Change From Baseline in Number of Non Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data

  • Change From Baseline in Number of Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes based on 24-hour impedance monitoring data

  • Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Number of reflux episodes based on 24-hour impedance monitoring data

  • Change From Baseline in Mean Bolus Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Based on 24-hour impedance monitoring data

  • Change From Baseline in Mean Acid Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Based on 24-hour impedance monitoring data

  • Change From Baseline in Percentage Time With pH<4.0 [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Percentage time with pH<4 during 24-hour pH monitoring

  • Change From Baseline in Percentage Time With pH Within 4.0-6.9 [ Time Frame: Baseline and end of treatment (10-14 days) ] [ Designated as safety issue: No ]
    Percentage time with pH 4.0-6.9 during 24-hour pH monitoring


Enrollment: 32
Study Start Date: October 2006
Study Completion Date: April 2009
  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Full-term or gestational age >/= 28 to 44 weeks
  • In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
  • Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

  • Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
  • Patients with any condition that may require surgery during the course of the study
  • Patients with acute respiratory distress within 72 hours prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427635

Locations
Australia
Research Site
North Adelaide, Australia
Germany
Research Site
Aachen, Germany
United Kingdom
Research Site
Sheffield, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Marta Illueca, MD AstraZeneca
Study Director: Per Lundborg, MD AstraZeneca
Study Director: Kathryn Collison, MPH, MT(ASCP) AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00427635     History of Changes
Other Study ID Numbers: D9614C00004
Study First Received: January 25, 2007
Results First Received: April 19, 2010
Last Updated: December 2, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
neonates
infants
GERD
reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014