A Phase 2, Double Blind Study to Assess Dexlansoprazole Delayed-Release Capsules for Healing of EE and Maintenance of Healed EE in Pediatric Subjects

Phase 1

Conditions: Erosive Esophagitis in paediatric subjects aged 2 to 11 years
MedDRA version: 20.1Level: LLTClassification code 10063657Term: Erosive esophagitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-004507-73-LT

Lead Sponsor: Takeda Development Center Americas, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

1) 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 eDiary during screening.
3) 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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 76
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

1) 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) 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 results.
3) 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.
4) Known history of Barrett’s esophagus with dysplastic changes in the esophagus.
5) 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.
6) Active gastric or duodenal ulcers within 4 weeks prior to Day -1.
7) Subjects who are required to take prescription or nonprescription medications as listed in Excluded Medications and Treatment Section of the protocol (Section 7.3).
8) 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
Main Objective: 1) To assess the safety and effectiveness of treatment with QD oral administration of dexlansoprazole 30 or 60 mg for 8 weeks in pediatric subjects aged 2 to 11 years, inclusive, with EE.<br><br>2) To assess the safety and effectiveness of dexlansoprazole 15 or 30 mg QD in maintenance of healed EE for 16<br>weeks.;Secondary Objective: none;Primary end point(s): 1) Percentage of subjects with healing of EE by Week 8 as assessed by endoscopy.<br>2) Percentage of subjects who maintained healed EE for 16 weeks among the subjects who were healed by Week 8 as assessed by endoscopy.;Timepoint(s) of evaluation of this end point: Week 8 for initial assessment<br>Week 12 as maximum duration of healing phase of the trial<br>Week 24 or 28 during maintenance phase (depending on when healing phase is considered complete)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percentage of days without hurting or burning in the stomach, chest or throat over the first 8 weeks of treatment.<br>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 8.;Timepoint(s) of evaluation of this end point: Week 8 for initial assessment<br>Week 12 as maximum duration of healing phase of the trial<br>Week 24 or 28 during maintenance phase (depending on when healing phase is considered complete)

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