NCT01778101

Brief Summary

This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

January 13, 2013

Last Update Submit

September 11, 2013

Conditions

Preterm InfantsGastrointestinal Reflux

Keywords

preterm infantsrefluximpedancepHmonitoringlansoprazole

Outcome Measures

Primary Outcomes (1)

  • impedance pH monitoring

    number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability

    day14

Secondary Outcomes (5)

  • Symtomts of reflux_d5

    day 5

  • impedance pH monitoring_d10

    day10

  • impedance pH monitoring_d5

    day5

  • Symtomts of reflux_d10

    day 10

  • Symtomts of reflux_d14

    Symtomts of reflux_d14 day 14

Study Arms (1)

lansoprazole

EXPERIMENTAL

lansoprazole 1mg/kg twice a day for 14days

Drug: Lansoprazole

Interventions

LansoprazoleDRUG

lansoprazole 1mg/kg twice a day for 14days

Also known as: lanston LFDT
lansoprazole

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infant
  • documented gastrointestinal reflux by 24hr pH monitoring

You may not qualify if:

  • unstable vital sings
  • congenital anomaly in upper gastrointestinal tract incuding esophagus
  • drug history of H2 blocker during last 1 week
  • medication of warfarin, carbamazepine, phenytoin, rifampin
  • renal or hepatic dysfunction
  • inappropriate clinical conditions judged by researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-740, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Han-Suk Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2013

First Posted

January 29, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations

KR(1)