A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients

Phase 3 Completed 127 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Eisai Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).

Timeline

Start: 2009-01
Primary completion: 2011-01
Completion: 2011-01

Publications

Haddad I, Kierkus J, Tron E, Ulmer A, Hu P, Sloan S, Silber S, Leitz G. Efficacy and safety of rabeprazole in children (1-11 years) with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2013 Dec;57(6):798-807. doi: 10.1097/MPG.0b013e3182a4e718.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rabeprazole	Small molecule	0.5 mg/kg	Oral
Subject	Rabeprazole	Small molecule	1 mg/kg	Oral

A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients

Summary

Timeline

Publications

Drugs

Indications