A Phase 2, Double-Blind Study to Assess Dexlansoprazole Delayed-Release Capsules for Healing of EE and Maintenance of Healed EE in Pediatric Subjects
- Conditions
- Erosive EsophagitisMedDRA version: 20.1Level: LLTClassification code: 10063657Term: Erosive esophagitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-501350-11-00
- Lead Sponsor
- Takeda Development Center Americas Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Medical history of GERD symptoms for at least 3 months prior to Screening and history of at least 1 failed attempted withdrawal of prior PPI or acid suppressive therapy with return of symptoms upon withdrawal., Reported symptoms of hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days as recorded in the eDiary during screening, Endoscopic evidence of EE (LA Grade A-D) based on an endoscopy performed during the Screening Period or within 1 week prior to signing screening informed consent and assent (as applicable)
History of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole)., Evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant underlying disease or condition (other than the disease being studied), which may impact the ability of the subject to participate or potentially confound the study result, Any findings in medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial., Known history of Barrett's esophagus with dysplastic changes in the esophagus., History of the following: eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (>15 eosinophils per high-powered field [HPF]); a history of celiac disease or tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology; inflammatory bowel disease; or irritable bowel syndrome, Active gastric or duodenal ulcers within 4 weeks prior to Day -1, Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3)., Positive test results for Helicobacter pylori.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method