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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427635

Enrollment

Registered

2007-01-29

Start date

2006-10-31

Completion date

2009-04-30

Last updated

2010-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

neonates, infants, GERD, reflux

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.

Interventions

DRUGEsomeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring	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

Measure	Time frame	Description
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)	Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data
Change From Baseline in Number of Acidic Reflux Episodes	Baseline and end of treatment (10-14 days)	Number of reflux episodes (pH\<4.0) based on 24-hour impedance monitoring data
Change From Baseline in Number of Weakly Acidic Reflux Episodes	Baseline and end of treatment (10-14 days)	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	Baseline and end of treatment (10-14 days)	Number of reflux episodes (pH\>=7.0) based on 24-hour impedance monitoring data
Change From Baseline in Number of Liquid Acidic Reflux Episodes	Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data
Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux	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.
Change From Baseline in Mean Bolus Clearance Time	Baseline and end of treatment (10-14 days)	Based on 24-hour impedance monitoring data
Change From Baseline in Mean Acid Clearance Time	Baseline and end of treatment (10-14 days)	Based on 24-hour impedance monitoring data
Change From Baseline in Percentage Time With pH<4.0	Baseline and end of treatment (10-14 days)	Percentage time with pH\<4 during 24-hour pH monitoring
Change From Baseline in Percentage Time With pH Within 4.0-6.9	Baseline and end of treatment (10-14 days)	Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes	Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data

Countries

Australia, Germany, United Kingdom

Participant flow

Recruitment details

Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second

Participants by arm

Arm	Count
Esomeprazole Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.	26
Placebo Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.	26
Total	52

Withdrawals & dropouts

Period	Reason	FG000	FG001
Study Completion to Safety Follow-up	Lost to Follow-up	0	1
Treatment Phase	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Esomeprazole	Placebo	Total
Age Continuous	46.5 Days STANDARD_DEVIATION 30.3	46.5 Days STANDARD_DEVIATION 31.2	46.5 Days STANDARD_DEVIATION 30.5
Sex: Female, Male Female	15 Participants	15 Participants	30 Participants
Sex: Female, Male Male	11 Participants	11 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 6	7 / 7
serious Total, serious adverse events	0 / 6	3 / 7

Outcome results

Primary

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.