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
Overview
- Phase
- Phase 3
- Intervention
- Rabeprazole
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 517
- Primary Endpoint
- Rate of Non-recurrence at Week 52
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Arm A
Intervention: Rabeprazole
Arm B
Intervention: Rabeprazole
Arm C
Intervention: Rabeprazole
Arm D
Intervention: Rabeprazole
Outcomes
Primary Outcomes
Rate of Non-recurrence at Week 52
Time Frame: Week 52
The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence.
Secondary Outcomes
- Rate of Non-recurrence at Weeks 12 and 24(Weeks 12 and 24)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days))
- Cumulative Non-recurrence Rate at Week 52(Week 52)
- Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period(From Week 4 up to Week 52)
- Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period(From Week 4 up to Week 52)
- Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period(From Week 4 up to Week 52)
- Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period(From Week 4 up to Week 52)
- Frequency of Sleep Disorders During the Maintenance Therapy Period(From Week 4 up to Week 52)