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Current Trials

Gastrointestinal GERD A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term
A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term PDF Print E-mail

This study consists of 2 parts. A multi-center, short-term, double-blind, randomized, parallel group

study (Part 1), and a long-term, double-blind, maintenance study (Part 2) in pediatric subjects 1 to

11 years of age with endoscopically proven GERD. In Part 1, the study will consist of 3 phases: a

14-day screening phase, a double-blind treatment phase of 12 weeks, and an end-of-study or early

withdrawal phase followed by Part 2, which consists a of double-blind treatment continuation for

subjects who achieved healing

 

(grade 0 on the Hetzel and Dent classification or grade 0 on the

Histological Features of Reflux Esophagitis scale) during the short-term double-blind treatment phase