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Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

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Seoul National University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Premature Infants
Gastroesophageal Reflux

Treatments

Drug: Placebo
Drug: Lansoprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01946971
Konect-LASP

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

Under 6 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 2 patient groups

PL
Experimental group
Description:
Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
Treatment:
Drug: Lansoprazole
Drug: Placebo
LP
Experimental group
Description:
Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
Treatment:
Drug: Lansoprazole
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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