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Completed

NCT Number: NCT00427635

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

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.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, North Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

  2. Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes based on 24-hour impedance monitoring data

  3. Change From Baseline in Number of Acidic Reflux Episodes

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data

  4. Change From Baseline in Number of Weakly Acidic Reflux Episodes

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data

  5. Change From Baseline in Number of Non Acidic Reflux Episodes

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data

  6. Change From Baseline in Number of Liquid Acidic Reflux Episodes

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes based on 24-hour impedance monitoring data

  7. Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes

    Time frame: Baseline and end of treatment (10-14 days)

    Number of reflux episodes based on 24-hour impedance monitoring data

  8. Change From Baseline in Mean Bolus Clearance Time

    Time frame: Baseline and end of treatment (10-14 days)

    Based on 24-hour impedance monitoring data

  9. Change From Baseline in Mean Acid Clearance Time

    Time frame: Baseline and end of treatment (10-14 days)

    Based on 24-hour impedance monitoring data

  10. Change From Baseline in Percentage Time With pH<4.0

    Time frame: Baseline and end of treatment (10-14 days)

    Percentage time with pH<4 during 24-hour pH monitoring

  11. Change From Baseline in Percentage Time With pH Within 4.0-6.9

    Time frame: Baseline and end of treatment (10-14 days)

    Percentage time with pH 4.0-6.9 during 24-hour pH monitoring

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2009
First posted
Jan 29, 2007
Registry last updated
Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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