TAK-390MR_205

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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

Sex at Birth: Any
Age: Child (Birth - 17)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase II
Conditions Being Studied: Esophagitis

Study Purpose

To evaluate the safety an effectiveness of once daily oral administration of dexlnsoprazole 30 or 60 mg for healing of erosive esophagitis (EE) and dexlansoprazole 15, 30 mg, or placebo for maintenance of healed EE.

Principal Investigator
Thomas Sferra MD

Department/Division
Gastroenterology (Pediatrics)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

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UH IRB: SITE00001676
StudyID: 2022-0894
ClinicalTrials.gov: NCT02615184

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