Erosive Esophagitis Clinical Trial
Official title:
A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE
The main aims of the study are to check the - side effects and effectiveness of Dexlansoprazole in healing erosive esophagitis (EE) - side effects and effectiveness of Dexlansoprazole in maintaining healed EE in children. Participants will take Dexlansoprazole by mouth.
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal EE and maintain healing of EE in pediatric participants aged 2 to 11 years. This study will look at the healing of EE followed by maintained healing of EE in children who take dexlansoprazole. The study will be conducted in two periods; a Healing of EE Period and a Maintenance of Healed EE Period. Approximately 76 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 mg or dexlansoprazole 30 mg for 8 weeks during the Healing of EE Period. Following Week 8, participants will enter the Maintenance of Healed EE Period and will receive half their healing dose of dexlansoprazole, (i.e., either 30 mg, dexlansoprazole 15 mg). All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have heartburn symptoms in a diary. Participants who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24) and have maintained healing of EE as confirmed by endoscopy, will enter a Post-Treatment Follow up Period for up to 3 months after the last dose of study drug. During this period participants will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Participants who require an invasive procedure or treatment with a proton pump inhibitor (PPI) or histamine 2-receptor antagonist (H2RA) for gastroesophageal reflux disease (GERD)/EE will be discontinued from the Post-Treatment Follow-up Period and a Final Study Visit will be performed. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 10 months. Participants will make multiple visits to the clinic including a final visit 3 months after last dose of study drug for a follow-up assessment. ;
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