Clinical trial
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
Name
E3810-J081-311
Description
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.
Trial arms
Trial start
2013-09-01
Estimated PCD
2016-05-01
Trial end
2016-06-01
Status
Completed
Phase
Early phase I
Treatment
Rabeprazole
Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
Arms:
Arm A
Other names:
E3810
Rabeprazole
Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
Arms:
Arm B
Other names:
E3810
Rabeprazole
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).
Arms:
Arm C
Other names:
E3810
Rabeprazole
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).
Arms:
Arm D
Other names:
E3810
Size
517
Primary endpoint
Rate of Non-recurrence at Week 52
Week 52
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 517, 'type': 'ACTUAL'}}
Updated at
2023-06-22
1 organization
1 product
1 indication
Organization
EisaiProduct
RabeprazoleIndication
Gastroesophageal Reflux Disease