Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

Phase 1

Completed

• Conditions: Gastroesophageal Reflux; Premature Infants
• Interventions: Drug: Lansoprazole; Drug: Placebo

• Registration Number: NCT01946971
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PL	Placebo	Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
LP	Placebo	Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
PL	Lansoprazole	Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
LP	Lansoprazole	Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days

Primary Outcome Measures

Name	Time	Method
Acid reflux time (%)	day 0, day 7, day 14	measured by 24hr pH impedance monitor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of