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

A Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis

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.

Study Overview

• Status: Completed
• Conditions: Esophagitis, Reflux
• Intervention / Treatment: Drug: Z-215 10mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo; Drug: Z-215 20mg; Drug: Rabeprazole Sodium

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Z-215 10 mg/day; Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo	Drug: Z-215 10mg; Z-215 10mg, capsules; Drug: Z-215 Placebo; Z-215 placebo-matching capsules; Drug: Rabeprazole Sodium Placebo; Rabeprazole Sodium Placebo placebo-matching tablets
Experimental: Z-215 20 mg/day; Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo	Drug: Z-215 Placebo; Z-215 placebo-matching capsules; Drug: Rabeprazole Sodium Placebo; Rabeprazole Sodium Placebo placebo-matching tablets; Drug: Z-215 20mg; Z-215 20mg, capsules
Experimental: Z-215 40 mg/day; Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo	Drug: Rabeprazole Sodium Placebo; Rabeprazole Sodium Placebo placebo-matching tablets; Drug: Z-215 20mg; Z-215 20mg, capsules
Active Comparator: Rabeprazole Sodium 10 mg/day; Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium	Drug: Z-215 Placebo; Z-215 placebo-matching capsules; Drug: Rabeprazole Sodium; Rabeprazole Sodium 10mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: Z215-01