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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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
Sex
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
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
32
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
Trial website
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

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