To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg 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 Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis

Conditions
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Esophagitis, Reflux

Intervention / Treatment
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* Drug: Z-215 10mg
* Drug: Z-215 20mg
* Drug: Z-215 Placebo
* Drug: Rabeprazole Sodium
* Drug: Rabeprazole Sodium Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In 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 20% (96 participants) or more of the total participants. Outpatient (including inpatient for examination) Exclusion Criteria: Participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, Barrett's esophagus ( columnar epithelium metaplasia>=3 cm ) or high-grade dysplasia.However, participants with Schatzki's ring ( >=20mm ) are allowed to be included. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating>=3mm) within 28 days prior to observation period . Participants with above disease at endoscopy during the observation period. Participants with Zollinger-Ellison syndrome.Participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others. Participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .

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: Z-215 10 mg/day<br>Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo | Drug: Z-215 10mg<br>* Z-215 10mg, capsules<br>Drug: Z-215 Placebo<br>* Z-215 placebo-matching capsules<br>Drug: Rabeprazole Sodium Placebo<br>* Rabeprazole Sodium Placebo placebo-matching tablets<br>|
| Experimental: Z-215 20 mg/day<br>Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo | Drug: Z-215 20mg<br>* Z-215 20mg, capsules<br>Drug: Z-215 Placebo<br>* Z-215 placebo-matching capsules<br>Drug: Rabeprazole Sodium Placebo<br>* Rabeprazole Sodium Placebo placebo-matching tablets<br>|
| Experimental: Z-215 40 mg/day<br>Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo | Drug: Z-215 20mg<br>* Z-215 20mg, capsules<br>Drug: Rabeprazole Sodium Placebo<br>* Rabeprazole Sodium Placebo placebo-matching tablets<br>|
| Active Comparator: Rabeprazole Sodium 10 mg/day<br>Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium | Drug: Z-215 Placebo<br>* Z-215 placebo-matching capsules<br>Drug: Rabeprazole Sodium<br>* Rabeprazole Sodium 10mg tablets<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 |  | 8 weeks | 

Secondary Outcome Measures

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