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 Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 503
- Primary Endpoint
- Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) .
Arms & Interventions
Z-215 10 mg/day
Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Z-215 Placebo (Drug)
Z-215 10 mg/day
Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Z-215 10mg (Drug)
Z-215 10 mg/day
Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Rabeprazole Sodium Placebo (Drug)
Z-215 20 mg/day
Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Z-215 20mg (Drug)
Z-215 20 mg/day
Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Z-215 Placebo (Drug)
Z-215 20 mg/day
Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo
Intervention: Rabeprazole Sodium Placebo (Drug)
Z-215 40 mg/day
Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo
Intervention: Z-215 20mg (Drug)
Z-215 40 mg/day
Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo
Intervention: Rabeprazole Sodium Placebo (Drug)
Rabeprazole Sodium 10 mg/day
Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium
Intervention: Z-215 Placebo (Drug)
Rabeprazole Sodium 10 mg/day
Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium
Intervention: Rabeprazole Sodium (Drug)
Outcomes
Primary Outcomes
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Time Frame: 8 weeks
Secondary Outcomes
- Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis(4 weeks)