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Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

NCT ID: NCT01946971

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-07-31

Brief Summary

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This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.

Detailed Description

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Conditions

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Premature Infants Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PL

Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

Placebo

Intervention Type DRUG

LP

Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Lansoprazole

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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lanston LFDT

Eligibility Criteria

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Inclusion Criteria

* preterm infant
* symptoms suspecting gastroesophageal reflux

Exclusion Criteria

* unstable general conditions due infection or acute illness
* congenital anomaly in upper gastrointestinal tract including esophagus
* drug history of H2, proton pump inhibitor, blocker during last 1 week
* medication of warfarin, carbamazepine, phenytoin, rifampin
* inappropriate clinical conditions judged by researchers
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Konect-LASP

Identifier Type: -

Identifier Source: org_study_id