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

NCT ID: NCT00427635

Last Updated: 2010-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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GERD

Keywords

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neonates infants GERD reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Esomeprazole

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Marta Illueca, MD

Role: STUDY_DIRECTOR

AstraZeneca

Per Lundborg, MD

Role: STUDY_DIRECTOR

AstraZeneca

Kathryn Collison, MPH, MT(ASCP)

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

North Adelaide, , Australia

Site Status

Research Site

Aachen, , Germany

Site Status

Research Site

Sheffield, , United Kingdom

Site Status

Countries

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Australia Germany United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23800403 (View on PubMed)

Other Identifiers

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D9614C00004

Identifier Type: -

Identifier Source: org_study_id