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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00427635
Registration number
NCT00427635
Ethics application status
Date submitted
25/01/2007
Date registered
29/01/2007
Date last updated
20/12/2010
Titles & IDs
Public title
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
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Scientific 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
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Secondary ID [1]
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D9614C00004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
GERD
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [1]
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Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [2]
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Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
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Assessment method [2]
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Number of reflux episodes based on 24-hour impedance monitoring data
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Timepoint [2]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [3]
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Change From Baseline in Number of Acidic Reflux Episodes
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Assessment method [3]
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Number of reflux episodes (pH\<4.0) based on 24-hour impedance monitoring data
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Timepoint [3]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [4]
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Change From Baseline in Number of Weakly Acidic Reflux Episodes
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Assessment method [4]
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Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
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Timepoint [4]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [5]
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Change From Baseline in Number of Non Acidic Reflux Episodes
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Assessment method [5]
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Number of reflux episodes (pH\>=7.0) based on 24-hour impedance monitoring data
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Timepoint [5]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [6]
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Change From Baseline in Number of Liquid Acidic Reflux Episodes
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Assessment method [6]
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Number of reflux episodes based on 24-hour impedance monitoring data
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Timepoint [6]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [7]
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Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
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Assessment method [7]
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Number of reflux episodes based on 24-hour impedance monitoring data
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Timepoint [7]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [8]
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Change From Baseline in Mean Bolus Clearance Time
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Assessment method [8]
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Based on 24-hour impedance monitoring data
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Timepoint [8]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [9]
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Change From Baseline in Mean Acid Clearance Time
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Assessment method [9]
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Based on 24-hour impedance monitoring data
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Timepoint [9]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [10]
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Change From Baseline in Percentage Time With pH<4.0
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Assessment method [10]
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Percentage time with pH\<4 during 24-hour pH monitoring
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Timepoint [10]
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Baseline and end of treatment (10-14 days)
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Secondary outcome [11]
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Change From Baseline in Percentage Time With pH Within 4.0-6.9
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Assessment method [11]
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Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
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Timepoint [11]
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Baseline and end of treatment (10-14 days)
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
1
Month
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - North Adelaide
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Recruitment postcode(s) [1]
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- North Adelaide
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Aachen
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Country [2]
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United Kingdom
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State/province [2]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00427635
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Trial related presentations / publications
Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.
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Public notes
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Contacts
Principal investigator
Name
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Marta Illueca, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00427635
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