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Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole

Gastroesophageal Reflux Disease Clinical Trial

Official title:
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients

Clinical Trial Summary

The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00132496
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 2
Start date August 2005
Completion date July 2006
View Details
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