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

Esophagitis, Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463643
• Other study ID #: Z215-01
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2015
• Last updated: June 28, 2017
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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) .

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Esophagitis, Reflux

Intervention

Drug:
• Z-215 10mg
Z-215 10mg, capsules
• Z-215 20mg
Z-215 20mg, capsules
• Z-215 Placebo
Z-215 placebo-matching capsules
• Rabeprazole Sodium
Rabeprazole Sodium 10mg tablets
• Rabeprazole Sodium Placebo
Rabeprazole Sodium Placebo placebo-matching tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis		8 weeks
Secondary	Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis		4 weeks