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

Phase 2

Completed

• Conditions: Esophagitis, Reflux
• Interventions: Drug: Z-215 Placebo; Drug: Z-215 20mg; Drug: Z-215 10mg; Drug: Rabeprazole Sodium; Drug: Rabeprazole Sodium Placebo

• Registration Number: NCT02463643
• Lead Sponsor: Zeria Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Primary Completion: 2016-10
• Study Completion: 2017-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rabeprazole Sodium 10 mg/day	Rabeprazole Sodium	Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium
Rabeprazole Sodium 10 mg/day	Z-215 Placebo	Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium
Z-215 10 mg/day	Z-215 Placebo	Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 20 mg/day	Z-215 20mg	Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 20 mg/day	Z-215 Placebo	Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 10 mg/day	Rabeprazole Sodium Placebo	Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 10 mg/day	Z-215 10mg	Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 40 mg/day	Z-215 20mg	Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo
Z-215 20 mg/day	Rabeprazole Sodium Placebo	Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 40 mg/day	Rabeprazole Sodium Placebo	Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo

Primary Outcome Measures

Name	Time	Method
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis	8 weeks

Secondary Outcome Measures

Name	Time	Method
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis	4 weeks