A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive

Summary

The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with Gastroesophageal Reflux Disease (GERD).

Timeline

Start

2007-12

Primary completion

2012-02

Completion

2012-02

Publications

• Treem W, Hu P, Sloan S. Normal and proton pump inhibitor-mediated gastrin levels in infants 1 to 11 months old. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):520-6. doi: 10.1097/MPG.0b013e31829b6914.

Drugs

Indications