Erosive Esophagitis in paediatric subjects aged 1 to 11 years MedDRA version: 19.0 Level: LLT Classification code 10063657 Term: Erosive esophagitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: Dexlansoprazole Delayed-Release Capsules
Product Code: TAK-390MR
Pharmaceutical Form: Capsule
INN or Proposed INN: Dexlansoprazole
CAS Number: 138530-94-6
Other descriptive name: DEXLANS
Sponsors
Takeda Development Centre Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who have a 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. 2) 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 electronic daily diary (eDiary) during Screening. 3) The subject has endoscopic evidence of EE (HD Grade >2) based on an endoscopy performed during the Screening Period or within 1 week prior to signing informed consent and assent (as applicable). Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subjects who have a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or antacid or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole). 2) Subjects with evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled 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 results or clinically significant finding from physical examinations or clinical laboratory results as deemed by the investigator. 3) Subjects with known history ofBarrett’s esophagus with dysplastic changes in the esophagus. Subjects with 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 antibody (tTG) antibody or confirmed disease by histology, inflammatory bowel disease, or irritable bowel syndrome. 4) Subjects with active gastric or duodenal ulcers within 4 weeks prior to Day -1. 5) Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol. 6) Subjects who test positive for Helicobacter pylori (H. pylori.) However, subjects who are positive and have received therapeutically approved eradication therapy within the past 6 months will be allowed to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To assess the safety and effectiveness of treatment with QD oral administration of dexlansoprazole 30 or 60 mg for 8 to 12 weeks in pediatric subjects aged 1 to 11 years, inclusive, with EE. 2) To assess the safety and effectiveness of dexlansoprazole 15 or 30 mg compared to placebo in maintenance of healed EE for 16 weeks.;Secondary Objective: none;Primary end point(s): 1) Percentage of subjects with healing of EE by Week 12 as assessed by endoscopy. 2) Percentage of subjects who maintained healed EE for 16 weeks among the subjects who were healed by Week 12 as assessed by endoscopy.;Timepoint(s) of evaluation of this end point: Week 8 for initial assessment Week 12 as maximum duration of healing phase of the trial Week 24 or 28 during maintenance phase (depending on when healing phase is considered complete) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Percentage of days without hurting or burning in the stomach, chest or throat over the first 8 or 12 weeks of treatment. 2) Percentage of days without hurting or burning in the stomach, chest or throat over Weeks 8 to 24 or Weeks 12 to 28 among subjects who were healed by Week 12.;Timepoint(s) of evaluation of this end point: Week 8 for initial assessment Week 12 as maximum duration of healing phase of the trial Week 24 or 28 during maintenance phase (depending on when healing phase is considered complete) | — |
Countries
Belgium, Brazil, Israel, Italy, Lithuania, Mexico, Poland, Portugal, United States
Contacts
Public ContactProgram Manager
Takeda Development Centre Europe Ltd.
Outcome results
None listed