NCT01946971

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

September 12, 2013

Last Update Submit

November 17, 2014

Conditions

Premature InfantsGastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Acid reflux time (%)

    measured by 24hr pH impedance monitor

    day 0, day 7, day 14

Secondary Outcomes (7)

  • Acid reflux frequency

    day 0, day 7, day 14

  • Composite score

    day 0, day 7, day 14

  • Acid reflux fraction

    day 0, day 7, day 14

  • acid bolus reflux time/%,

    day 0, day 7, day 14

  • nonacid bolus reflux time/%

    day 0, day 7, day 14

  • +2 more secondary outcomes

Study Arms (2)

PL

EXPERIMENTAL

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

Drug: LansoprazoleDrug: Placebo

LP

EXPERIMENTAL

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

Drug: LansoprazoleDrug: Placebo

Interventions

LansoprazoleDRUG
Also known as: lanston LFDT
LPPL
PlaceboDRUG
LPPL

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infant
  • symptoms suspecting gastroesophageal reflux

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-740, South Korea

Location

MeSH Terms

Conditions

Premature BirthGastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEsophageal 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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 20, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)