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

Primary Purpose

Esophagitis, Reflux

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Z-215 10mg

Z-215 20mg

Z-215 Placebo

Rabeprazole Sodium

Rabeprazole Sodium Placebo

About this trial

This is an interventional treatment trial for Esophagitis, Reflux

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) .

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Z-215 10 mg/day

Z-215 20 mg/day

Z-215 40 mg/day

Rabeprazole Sodium 10 mg/day

Arm Description

Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo

Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium

Outcomes

Primary Outcome Measures

Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis

Secondary Outcome Measures

Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

Full Information

NCT ID

NCT02463643

First Posted

June 2, 2015

Last Updated

June 28, 2017

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02463643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagitis, Reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

503 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Z-215 10 mg/day

Arm Type

Experimental

Arm Description

Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Arm Title

Z-215 20 mg/day

Arm Type

Experimental

Arm Description

Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Arm Title

Z-215 40 mg/day

Arm Type

Experimental

Arm Description

Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo

Arm Title

Rabeprazole Sodium 10 mg/day

Arm Type

Active Comparator

Arm Description

Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium

Intervention Type

Drug

Intervention Name(s)

Z-215 10mg

Intervention Description

Z-215 10mg, capsules

Intervention Type

Drug

Intervention Name(s)

Z-215 20mg

Intervention Description

Z-215 20mg, capsules

Intervention Type

Drug

Intervention Name(s)

Z-215 Placebo

Intervention Description

Z-215 placebo-matching capsules

Intervention Type

Drug

Intervention Name(s)

Rabeprazole Sodium

Intervention Description

Rabeprazole Sodium 10mg tablets

Intervention Type

Drug

Intervention Name(s)

Rabeprazole Sodium Placebo

Intervention Description

Rabeprazole Sodium Placebo placebo-matching tablets

Primary Outcome Measure Information:

Title

Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) .

Facility Information:

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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