Gastroesophageal Reflux Clinical Trial
Official title:
A Phase 1, Randomized, Open-Label, Parallel Design, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Delayed Release Capsules in Pediatric Subjects Ages 1 to 11 Years Old With Symptomatic Gastroesophageal Reflux Disease
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the
backward flow of gastric contents into the esophagus through the lower esophageal sphincter.
The prevalence of GERD in the pediatric population is increasingly becoming recognized and
documented. It is a disease that may persist through adulthood, with symptoms in older
children and adolescents similar to those seen in adults.
Younger children generally present with extra-esophageal manifestations, regurgitation, and
epigastric pain, while older children and adolescents typically present with adult-type GERD
symptoms of heartburn and regurgitation. Treatment for GERD is aimed at improving symptoms
and healing esophageal inflammation.
Takeda Global Research & Development Center, Inc. (TGRD) developed dexlansoprazole delayed
release capsules as a new therapy for treating acid related disorders including symptomatic
non-erosive GERD, healing of erosive esophagitis (EE) and maintenance of healed EE.
Dexlansoprazole delayed release capsules have not been studied in subjects younger than 12
years of age. This study is designed to evaluate the safety of dexlansoprazole delayed
release capsules in the pediatric population (1 to 11 years old) and to determine if the PK
profile of dexlansoprazole in subjects 1 to 11 years of age is similar to that in adults
given a similar dose.
Subjects who satisfy the screening evaluation and Inclusion/Exclusion Criteria may be
enrolled in the study. Eligible subjects will be assigned to one of three treatment groups.
Attempts will be made to enroll an equal number of male and female subjects in each
treatment group.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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