Gastroesophageal Reflux Esophagitis
Conditions
Interventions
investigational material(s)
Generic name etc : E3810
INN of investigational material : Rabeprazole Sodium
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for Investig
Sponsors
EA Pharma Co., Ltd., Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with gastroesophageal reflux disease who are shown through endoscopic examination to have mucosal lesions (erosions, ulcers) 2.Patients over 20 years of age who have freely given their informed consent in writing to participation in the study. 3.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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Rate of non-recurrence according to endoscopic findings (modified Los Angeles Classification) after the 52nd week of the maintenance therapy period endoscopic findings | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Rate of non-recurrence according to endoscopic findings (modified Los Angeles Classification) after the12th and 24th week of the maintenance therapy period endoscopic findings | — |
Countries
Japan
Outcome results
None listed