Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.

• Proton Pump Inhibitor standard dose-resistant reflux esophagitis.

• Patients who are 20 years and older when informed consent is obtained.

Exclusion Criteria:

• Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.

• Patients with malignancy.

• Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.