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

NCT02463643 — Phase 2, Completed, 503 participants, Zeria Pharmaceutical

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

Registry	NCT02463643
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	503 (Actual)
Sponsor	Zeria Pharmaceutical (Industry)
Conditions	Esophagitis, Reflux
Interventions	Z-215 10mg, Z-215 20mg, Z-215 Placebo, Rabeprazole Sodium, Rabeprazole Sodium Placebo (Drug)
Dates	start 2015-05-01, primary completion 2016-10-01, completion 2017-03-01, first posted 2015-06-04, last updated 2017-07-02
Locations	1 site in Japan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Z-215 10 mg/day	Experimental	Drug: Z-215 10mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo	Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 20 mg/day	Experimental	Drug: Z-215 20mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo	Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Z-215 40 mg/day	Experimental	Drug: Z-215 20mg; Drug: Rabeprazole Sodium Placebo	Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo
Rabeprazole Sodium 10 mg/day	Active comparator	Drug: Z-215 Placebo; Drug: Rabeprazole Sodium	Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium

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

+Outcome measures

Primary outcomes

Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis [8 weeks]

Secondary outcomes

Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis [4 weeks]

+Eligibility

Sex: All, ages: 20 Years to any

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) .

+Locations (1)

Facility	City	Country	Status
	Tokyo	Japan

My Notes

Public

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