Study Evaluating Pantoprazole in Children With GERD

Phase 3 Completed 41 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Timeline

Start: 2005-08
Primary completion: 2007-11
Completion: 2007-11

Publications

Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pantoprazole	Other / unclassified	0.6 mg/kg	—
Subject	Pantoprazole	Other / unclassified	1.2 mg/kg	—

Study Evaluating Pantoprazole in Children With GERD

Summary

Timeline

Publications

Drugs

Indications