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
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks. The 8-week Treatment Period (unblinded) was followed by a 52-week Maintenance Period (blinded). Participants with cure (modified Los Angeles Classification Grade N or Grade M) at the final endoscopy of the Treatment Period were entered into the Maintenance Period. Participants without cure were discontinued from the study. The participants in the Treatment Period were randomized to take Arm C or Arm D at a ratio of 1:1. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects fulfilling all of the below criteria shall be eligible for the study:
- Patients diagnosed with gastroesophageal reflux disease who are shown through endoscopic examination to have mucosal lesions (erosions, ulcers)
- Patients shown through endoscopy not to have recovered despite administration of PPI once daily for eight weeks.
- Patients over 20 years of age who have freely given their informed consent in writing to participation in the study.
- 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:
- Patients considered candidates for surgical treatment of the upper gastrointestinal tract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices, etc.
- Patients with Zollinger-Ellison syndrome.
- Patients with gastrointestinal hemorrhage.
- Patients with serious cardiovascular disease, cerebrovascular disease, hematological disorders, renal disease, liver disease, malignant tumors, etc.
- Patients with long segment Barrett's esophagus.
- Patients with open gastric or duodenal ulcers.
- Patients with drug allergies or a past history of drug allergies to PPI.
- Patients who are taking other drugs under development, or have done so within 12 weeks prior to enrollment.
- 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.
- Patients with a history of dependence on or abuse of drugs or alcohol within the past two years.
- Other patients deemed unsuitable for inclusion in the study by the principal investigator or sub-investigators.
Trial design
Primary purpose
Allocation
Interventional model
Masking
517 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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