drugset / Trial / NCT00324974

The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

NCT00324974

Phase 3 Completed 162 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

Timeline

Start
2006-06
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Lansoprazole Other / unclassified 0.2 mg/kg Oral
Subject Lansoprazole Other / unclassified 0.3 mg/kg Oral
Subject Lansoprazole Other / unclassified 1 mg/kg Oral
Subject Lansoprazole Other / unclassified 1.5 mg/kg Oral