Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

November 17, 2014 updated by: Han-Suk Kim, Seoul National University Hospital

Lansoprazole in Preterm Infants With Gastroesophageal Reflux

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-740
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PL
Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
Drug: Placebo
Drug: Lansoprazole
Other Names:
  • lanston LFDT
Experimental: LP
Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
Drug: Placebo
Drug: Lansoprazole
Other Names:
  • lanston LFDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acid reflux time (%)
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acid reflux frequency
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
Composite score
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
Acid reflux fraction
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
acid bolus reflux time/%,
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
nonacid bolus reflux time/%
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
bolus reflux time/%
Time Frame: day 0, day 7, day 14
measured by 24hr pH impedance monitor
day 0, day 7, day 14
I-GERQ GERD score
Time Frame: day 0, day 7, day 14
I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)
day 0, day 7, day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Konect-LASP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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