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

NCT02463643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Esophagitis, Reflux

Interventions

DRUG

Z-215 10mg

Z-215 10mg, capsules

DRUG

Z-215 20mg

Z-215 20mg, capsules

DRUG

Z-215 Placebo

Z-215 placebo-matching capsules

DRUG

Rabeprazole Sodium

Rabeprazole Sodium 10mg tablets

DRUG

Rabeprazole Sodium Placebo

Rabeprazole Sodium Placebo placebo-matching tablets

Sponsors & Collaborators

  • Zeria Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-10-31
Completion
2017-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463643 on ClinicalTrials.gov