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

Zeria Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Esophagitis, Reflux

Treatments: Drug: Z-215 10mg; Drug: Z-215 Placebo; Drug: Z-215 20mg; Drug: Rabeprazole Sodium Placebo; Drug: Rabeprazole Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT02463643

Z215-01

Details and patient eligibility

About

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.

Enrollment: 503 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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) .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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503 participants in 4 patient groups

Z-215 10 mg/day

Experimental group

Description:

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

Treatment:

Drug: Z-215 10mg

Drug: Rabeprazole Sodium Placebo

Drug: Z-215 Placebo

Z-215 20 mg/day

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole Sodium Placebo

Drug: Z-215 Placebo

Drug: Z-215 20mg

Z-215 40 mg/day

Experimental group

Description:

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

Treatment:

Drug: Rabeprazole Sodium Placebo

Drug: Z-215 20mg

Rabeprazole Sodium 10 mg/day

Active Comparator group

Description:

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

Treatment:

Drug: Rabeprazole Sodium

Drug: Z-215 Placebo