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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

NCT02509923

Healthy

COMPLETED PHASE1

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

NCT02456935

Erosive Esophagitis

COMPLETED PHASE3

A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

NCT00206245

GERD With Erosive Esophagitis

COMPLETED PHASE2

Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

NCT00644735

Erosive Esophagitis

COMPLETED PHASE4

A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.

NCT00206284

GERD Without Erosive Esophagitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophagitis, Reflux

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Z-215 10 mg/day

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

Group Type EXPERIMENTAL

Z-215 10mg

Intervention Type DRUG

Z-215 10mg, capsules

Z-215 Placebo

Intervention Type DRUG

Z-215 placebo-matching capsules

Rabeprazole Sodium Placebo

Intervention Type DRUG

Rabeprazole Sodium Placebo placebo-matching tablets

Z-215 20 mg/day

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

Group Type EXPERIMENTAL

Z-215 20mg

Intervention Type DRUG

Z-215 20mg, capsules

Z-215 Placebo

Intervention Type DRUG

Z-215 placebo-matching capsules

Rabeprazole Sodium Placebo

Intervention Type DRUG

Rabeprazole Sodium Placebo placebo-matching tablets

Z-215 40 mg/day

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

Group Type EXPERIMENTAL

Z-215 20mg

Intervention Type DRUG

Z-215 20mg, capsules

Rabeprazole Sodium Placebo

Intervention Type DRUG

Rabeprazole Sodium Placebo placebo-matching tablets

Rabeprazole Sodium 10 mg/day

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

Group Type ACTIVE_COMPARATOR

Z-215 Placebo

Intervention Type DRUG

Z-215 placebo-matching capsules

Rabeprazole Sodium

Intervention Type DRUG

Rabeprazole Sodium 10mg tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Z-215 10mg

Z-215 10mg, capsules

Intervention Type DRUG

Z-215 20mg

Z-215 20mg, capsules

Intervention Type DRUG

Z-215 Placebo

Z-215 placebo-matching capsules

Intervention Type DRUG

Rabeprazole Sodium

Rabeprazole Sodium 10mg tablets

Intervention Type DRUG

Rabeprazole Sodium Placebo

Rabeprazole Sodium Placebo placebo-matching tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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) .

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No