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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427635
• Other study ID #: D9614C00004
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2007
• Last updated: December 2, 2010
• Start date: October 2006
• Est. completion date: April 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Australia	Research Site	North Adelaide
Germany	Research Site	Aachen
United Kingdom	Research Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and end of treatment (10-14 days)	No
Secondary	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.	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Number of Acidic Reflux Episodes	Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	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	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Number of Non Acidic Reflux Episodes	Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Number of Liquid Acidic Reflux Episodes	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Mean Bolus Clearance Time	Based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Mean Acid Clearance Time	Based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)	No
Secondary	Change From Baseline in Percentage Time With pH<4.0	Percentage time with pH<4 during 24-hour pH monitoring	Baseline and end of treatment (10-14 days)	No
Secondary	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	Baseline and end of treatment (10-14 days)	No

External Links

•   AstraZeneca Clinical Trial Information