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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014