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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02463643

Enrollment

503

Registered

2015-06-04

Start date

2015-05-31

Completion date

2017-03-31

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagitis, Reflux

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.

Interventions

DRUGZ-215 Placebo

Z-215 placebo-matching capsules

DRUGRabeprazole Sodium

Rabeprazole Sodium 10mg tablets

DRUGRabeprazole Sodium Placebo

Rabeprazole Sodium Placebo placebo-matching tablets

DRUGZ-215 10mg

Z-215 10mg, capsules

DRUGZ-215 20mg

Z-215 20mg, capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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) .

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026