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

History of Changes

Results First Received: April 19, 2010

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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.
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.

Participant Flow for 2 periods

Period 1: Treatment Phase

	Esomeprazole	Placebo
STARTED	26 ^[1]	26 ^[1]
COMPLETED	25 ^[2]	26 ^[3]
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

[1]	Randomised
[2]	ITT population. One voluntary discontinuation by parent/guardian
[3]	ITT population

Period 2: Study Completion to Safety Follow-up

	Esomeprazole	Placebo
STARTED	25	26
COMPLETED	25	25 ^[1]
NOT COMPLETED	0	1
Lost to Follow-up	0	1

[1]	One participant lost to follow-up

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Esomeprazole	Placebo	Total
Number of Participants [units: participants]	26	26	52
Age [units: Days] Mean ± Standard Deviation	46.5 ± 30.3	46.5 ± 31.2	46.5 ± 30.5
Gender [units: Participants]
Female	15	15	30
Male	11	11	22

Outcome Measures

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1. Primary:

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) ]

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Measure Type	Primary
Measure Title	Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
Measure 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	Baseline and end of treatment (10-14 days)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.
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.

Measured Values

	Esomeprazole	Placebo
Number of Participants Analyzed [units: participants]	25	26
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring [units: Mean Number of Events] Mean ± Standard Deviation	-28.01 ± 77.70	-24.79 ± 44.25

No statistical analysis provided for Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring

2. Secondary:

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) ]

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3. Secondary:

Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) [ Time Frame: Baseline and end of treatment (10-14 days) ]

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4. Secondary:

Change From Baseline in Number of Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]

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5. Secondary:

Change From Baseline in Number of Weakly Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]

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6. Secondary:

Change From Baseline in Number of Non Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]

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7. Secondary:

Change From Baseline in Number of Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]

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8. Secondary:

Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]

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9. Secondary:

Change From Baseline in Mean Bolus Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ]

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10. Secondary:

Change From Baseline in Mean Acid Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ]

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11. Secondary:

Change From Baseline in Percentage Time With pH<4.0 [ Time Frame: Baseline and end of treatment (10-14 days) ]

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12. Secondary:

Change From Baseline in Percentage Time With pH Within 4.0-6.9 [ Time Frame: Baseline and end of treatment (10-14 days) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

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

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