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

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

Outcome

Missed primary endpoint

paper Of those, 44/81 infants (54%) in each group were responders--identical for lansoprazole and placebo. PMID 19054529 ↗

paper This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. PMID 19054529 ↗

Publications

• Results Orenstein SR, Hassall E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr. 2009 Apr;154(4):514-520.e4. doi: 10.1016/j.jpeds.2008.09.054. Epub 2008 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
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

Indications