Phase 3
N=517
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
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02135107 ↗Enrolled (actual)
517
Serious AEs
4.3%
Results posted
Nov 2018
Primary outcome: Primary: Rate of Non-recurrence at Week 52 — 44.8; 73.9; 55.2; 26.1 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rabeprazole (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Non-recurrence at Week 52 |
44.8; 73.9; 55.2; 26.1 | <0.001 sig |
| SECONDARY Rate of Non-recurrence at Weeks 12 and 24 |
62.5; 92.4; 37.5; 7.6; 55.8; 85.1 | <0.001 sig |
| SECONDARY Cumulative Non-recurrence Rate at Week 52 |
41.5; 71.4 | <0.001 sig |
| SECONDARY Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period |
23.2; 8.0; 76.8; 92.0 | <0.001 sig |
| SECONDARY Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period |
85.2; 85.1; 12.3; 11.2; 1.9; 0.6 | — |
| SECONDARY Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period |
85.2; 85.1; 14.8; 14.3; 0.0; 0.6 | — |
| SECONDARY Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period |
2.5; 2.5; 97.5; 97.5 | =0.992 |
| SECONDARY Frequency of Sleep Disorders During the Maintenance Therapy Period |
96.9; 98.1; 2.5; 0.6; 0.6; 0.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
111; 21; 111; 125; 20; 1 | — |
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT02135107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.