Overview

This trial is active, not recruiting.

Condition esophagitis, reflux
Treatments z-215 10mg, z-215 20mg, z-215 placebo, rabeprazole sodium, rabeprazole sodium placebo
Phase phase 2
Sponsor Zeria Pharmaceutical
Start date May 2015
End date October 2016
Trial size 480 participants
Trial identifier NCT02463643, Z215-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
z-215 10mg
Z-215 10mg, capsules
z-215 placebo
Z-215 placebo-matching capsules
rabeprazole sodium placebo
Rabeprazole Sodium Placebo placebo-matching tablets
(Experimental)
Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
z-215 20mg
Z-215 20mg, capsules
z-215 placebo
Z-215 placebo-matching capsules
rabeprazole sodium placebo
Rabeprazole Sodium Placebo placebo-matching tablets
(Experimental)
Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo
z-215 20mg
Z-215 20mg, capsules
rabeprazole sodium placebo
Rabeprazole Sodium Placebo placebo-matching tablets
(Active Comparator)
Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium
z-215 placebo
Z-215 placebo-matching capsules
rabeprazole sodium
Rabeprazole Sodium 10mg tablets

Primary Outcomes

Measure
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
time frame: 8 weeks

Secondary Outcomes

Measure
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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) .

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Zeria Pharmaceutical.