A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Rabeprazole; Rabeprazole; Rabeprazole; Rabeprazole
Intervention description: Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).; Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).; Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).; Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 517.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Gastroesophageal reflux disease

Summary:

      The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and
      twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects fulfilling all of the below criteria shall be eligible for the study:

          1. Patients diagnosed with gastroesophageal reflux disease who are shown through
             endoscopic examination to have mucosal lesions (erosions, ulcers)

          2. Patients shown through endoscopy not to have recovered despite administration of PPI
             once daily for eight weeks.

          3. Patients over 20 years of age who have freely given their informed consent in writing
             to participation in the study.

          4. Patients who, having received a full explanation of the matters that must be adhered
             to during the study, intend to adhere to their requirements, and are capable of doing
             so.

        Exclusion Criteria:

        Subjects fulfilling any of the following criteria shall be excluded from the study:

          1. Patients considered candidates for surgical treatment of the upper gastrointestinal
             tract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices,
             etc.

          2. Patients with Zollinger-Ellison syndrome.

          3. Patients with gastrointestinal hemorrhage.

          4. Patients with serious cardiovascular disease, cerebrovascular disease, hematological
             disorders, renal disease, liver disease, malignant tumors, etc.

          5. Patients with long segment Barrett's esophagus.

          6. Patients with open gastric or duodenal ulcers.

          7. Patients with drug allergies or a past history of drug allergies to PPI.

          8. Patients who are taking other drugs under development, or have done so within 12 weeks
             prior to enrollment.

          9. Patients who are, or may be pregnant, patients who wish to become pregnant during the
             study period, patients who are breastfeeding, and patients or their partners who do
             not wish to use reliable contraceptive measures.

         10. Patients with a history of dependence on or abuse of drugs or alcohol within the past
             two years.

         11. Other patients deemed unsuitable for inclusion in the study by the principal
             investigator or sub-investigators.