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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
D9614C00004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
GERD 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Esomeprazole

Treatment: Drugs: Esomeprazole


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [2] 0 0
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) - Number of reflux episodes based on 24-hour impedance monitoring data
Timepoint [2] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [3] 0 0
Change From Baseline in Number of Acidic Reflux Episodes - Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data
Timepoint [3] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [5] 0 0
Change From Baseline in Number of Non Acidic Reflux Episodes - Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data
Timepoint [5] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [6] 0 0
Change From Baseline in Number of Liquid Acidic Reflux Episodes - Number of reflux episodes based on 24-hour impedance monitoring data
Timepoint [6] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [7] 0 0
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes - Number of reflux episodes based on 24-hour impedance monitoring data
Timepoint [7] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [8] 0 0
Change From Baseline in Mean Bolus Clearance Time - Based on 24-hour impedance monitoring data
Timepoint [8] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [9] 0 0
Change From Baseline in Mean Acid Clearance Time - Based on 24-hour impedance monitoring data
Timepoint [9] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [10] 0 0
Change From Baseline in Percentage Time With pH<4.0 - Percentage time with pH<4 during 24-hour pH monitoring
Timepoint [10] 0 0
Baseline and end of treatment (10-14 days)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline and end of treatment (10-14 days)

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
Minimum age
No limit
Maximum age
1 Month
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - North Adelaide
Recruitment postcode(s) [1] 0 0
- North Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Aachen
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00427635
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marta Illueca, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications