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

Primary Purpose

GERD

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Esomeprazole

About this trial

This is an interventional treatment trial for GERD focused on measuring neonates, infants, GERD, reflux

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site

Outcomes

Primary Outcome Measures

Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring

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

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)

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

Change From Baseline in Number of Acidic Reflux Episodes

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

Change From Baseline in Number of Weakly Acidic Reflux Episodes

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

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

Change From Baseline in Number of Liquid Acidic Reflux Episodes

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

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

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

Change From Baseline in Mean Bolus Clearance Time

Based on 24-hour impedance monitoring data

Change From Baseline in Mean Acid Clearance Time

Based on 24-hour impedance monitoring data

Change From Baseline in Percentage Time With pH<4.0

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

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

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

Full Information

NCT ID

NCT00427635

First Posted

January 25, 2007

Last Updated

December 2, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00427635

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GERD

Keywords

neonates, infants, GERD, reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Primary Outcome Measure Information:

Title

Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring

Description

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.

Time Frame