Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

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

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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