Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

Phase 3 Completed 60 enrolled Wyeth is now a wholly owned subsidiary of Pfizer Nycomed · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Timeline

Start: 2006-05
Primary completion: 2008-04
Completion: 2008-04

Publications

Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pantoprazole	Other / unclassified	0.3 mg/kg	Oral
Comparator	Pantoprazole	Other / unclassified	0.6 mg/kg	Oral
Comparator	Pantoprazole	Other / unclassified	1.2 mg/kg	Oral

Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

Summary

Timeline

Publications

Drugs

Indications