Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) 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 confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.

Official Title
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A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-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
* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At Visit H-1 (start of the treatment period), the participants must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 15% or more of the total participants. Outpatients (including inpatient for examination) Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system. 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 H-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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAK-438 10 mg QD<br> | Drug: TAK-438<br>* In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.<br>|
| Experimental: TAK-438 20 mg QD<br> | Drug: TAK-438<br>* In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.<br>|
| Active Comparator: Lansoprazole 15 mg QD<br> | Drug: Lansoprazole<br>* In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.<br>* Other names: AG-1749;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment | Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference). | 24 Weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment |  | 12 Weeks. | 

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