To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
This trial is active, not recruiting.
|Treatments||z-215 10mg, z-215 20mg, z-215 placebo, rabeprazole sodium, rabeprazole sodium placebo|
|Start date||May 2015|
|End date||October 2016|
|Trial size||480 participants|
|Trial identifier||NCT02463643, Z215-01|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
time frame: 8 weeks
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
time frame: 4 weeks
Male or female participants at least 20 years old.
- 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)
- 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) .
|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|
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