Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.

Official Title
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A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis

Conditions
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Erosive Esophagitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At Visit 1 (start of the observation period), the participant 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 30% (120 participants) or more of the total participants. 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 1 (start of the observation period). 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 disorders

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 20 mg QD<br> | Drug: TAK-438<br>* TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.<br>Drug: Placebo<br>* Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.<br>* Other names: AG-1749;|
| Active Comparator: AG-1749 30 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.<br>* Other names: AG-1749;Drug: Placebo<br>* TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis | Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O 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). | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis |  | 2 Weeks | 
| Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis |  | 4 Weeks | 

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