Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Phase 2, Double-Blind, 12-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease
The main aims of the study are to see the - side effects of Dexlansoprazole treatment - effectiveness of Dexlansoprazole treatment in children having symptomatic nonerosive gastroesophageal reflux disease (GERD). Participants will take Dexlansoprazole by mouth once daily for 12 weeks
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat children aged 2 to 11 years who have nonerosive GERD. This study will look at the effectiveness and side effects of three different doses of dexlansoprazole in children with GERD. The study will enroll approximately 70 patients. Participants weighing ≤30 kg will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 15 or 30 mg, and participants who weigh >30 kg will be randomized to receive dexlansoprazole 30 or 60 mg. All participants will be asked to take one capsule at the same time each day throughout the study. Parents/caregivers for participants ages 2 to 8 and participants ages 9 to 11 will be asked to record any time they have heartburn symptoms in an electronic diary. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 16 weeks, which includes up to 4 weeks to screen for the study. Participants will make multiple visits to the clinic, plus a final phone call 5 to 10 days after last dose of study drug for a follow-up assessment. ;
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