search
Back to results

Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Primary Purpose

Premature Infants, Gastroesophageal Reflux

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprazole
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infants

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PL

LP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acid reflux time (%)
measured by 24hr pH impedance monitor

Secondary Outcome Measures

Acid reflux frequency
measured by 24hr pH impedance monitor
Composite score
measured by 24hr pH impedance monitor
Acid reflux fraction
measured by 24hr pH impedance monitor
acid bolus reflux time/%,
measured by 24hr pH impedance monitor
nonacid bolus reflux time/%
measured by 24hr pH impedance monitor
bolus reflux time/%
measured by 24hr pH impedance monitor
I-GERQ GERD score
I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)

Full Information

First Posted
September 12, 2013
Last Updated
November 17, 2014
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01946971
Brief Title
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
Official Title
Lansoprazole in Preterm Infants With Gastroesophageal Reflux
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PL
Arm Type
Experimental
Arm Description
Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
Arm Title
LP
Arm Type
Experimental
Arm Description
Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
lanston LFDT
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Acid reflux time (%)
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Secondary Outcome Measure Information:
Title
Acid reflux frequency
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
Composite score
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
Acid reflux fraction
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
acid bolus reflux time/%,
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
nonacid bolus reflux time/%
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
bolus reflux time/%
Description
measured by 24hr pH impedance monitor
Time Frame
day 0, day 7, day 14
Title
I-GERQ GERD score
Description
I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)
Time Frame
day 0, day 7, day 14

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-740
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

We'll reach out to this number within 24 hrs