Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.

Official Title
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A Phase 3, Randomized, Single-Blind, Multicenter Study to Evaluate the Safety of TAK-438 (10 and 20 mg Once-daily) in a 52-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE)

Conditions
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Erosive Esophagitis

Intervention / Treatment
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* Drug: TAK-438
* Drug: TAK-438


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4, or 8 in the preceding study.* * Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. Outpatient (including inpatient for examination) Exclusion Criteria: Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy) Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit M-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorder

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-438 10 mg QD<br> | Drug: TAK-438<br>* TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.<br>|
| Experimental: TAK-438 20 mg QD<br> | Drug: TAK-438<br>* TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-emergent Adverse Events | Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit. | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Laboratory Values |  | Baseline and Week 52 | 
| Change from Baseline in Electrocardiograms |  | Baseline and Week 52 | 
| Change from Baseline in Vital Signs |  | Baseline and Week 52 | 
| Change from Baseline in Serum Gastrin |  | Baseline and Week 52 | 
| Change from Baseline in Pepsinogen I and II |  | Baseline and Week 52 | 
| Endoscopically confirmed recurrence rate of Erosive Esophagitis |  | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy