Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux Erosive Esophagitis Pharmacokinetics Pediatrics Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole intervention 3: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days intervention 3: Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Protocol document: