Refractory Reflux Esophagitis
Conditions
Keywords
reflux esophagitis, rabeprazole, GERD, Japan
Brief summary
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
Detailed description
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.
Interventions
DRUGE3810
20 mg taken orally, once a day for 8 weeks.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis. * Proton Pump Inhibitor standard dose-resistant reflux esophagitis. * Patients who are 20 years and older when informed consent is obtained.
Exclusion criteria
* Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease. * Patients with malignancy. * Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 8 weeks | Grade N indicates a normal appearance of lower esophageal mucosa |
Countries
Japan
Participant flow
Recruitment details
This study was recruited at 71 centers in Japan during the period of 17-Oct-2008 to 12-Nov-2009.
Pre-assignment details
There was no run-in phase before assignment to E3810 treatment groups in this study.
Participants by arm
| Arm | Count |
|---|---|
| E3810 20 mg Once Daily E3810 20mg once daily orally for 8 weeks | 110 |
| E3810 10 mg Twice Daily E3810 10mg twice daily orally for 8 weeks | 111 |
| E3810 20 mg Twice Daily E3810 20mg twice daily orally for 8 weeks | 111 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 6 |
| Overall Study | Incorrect drug was allocated | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 0 | 1 |
| Overall Study | Refusal to continue participation | 6 | 4 | 5 |
Baseline characteristics
| Characteristic | E3810 20 mg Once Daily | E3810 10 mg Twice Daily | E3810 20 mg Twice Daily | Total |
|---|---|---|---|---|
| Age Continuous | 64.5 years STANDARD_DEVIATION 13.9 | 65.5 years STANDARD_DEVIATION 13.3 | 66.6 years STANDARD_DEVIATION 13.8 | 65.5 years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Asian | 110 participants | 111 participants | 111 participants | 332 participants |
| Sex: Female, Male Female | 53 Participants | 59 Participants | 62 Participants | 174 Participants |
| Sex: Female, Male Male | 57 Participants | 52 Participants | 49 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 112 | 25 / 111 | 20 / 114 |
| serious Total, serious adverse events | 3 / 112 | 6 / 111 | 5 / 114 |
Outcome results
Primary
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
Grade N indicates a normal appearance of lower esophageal mucosa
Time frame: 8 weeks
Population: The primary analysis was on the full analysis set (FAS) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E3810 20 mg Once Daily | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 58.8 Percentage of Participants |
| E3810 10 mg Twice Daily | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 78.4 Percentage of Participants |
| E3810 20 mg | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 77.0 Percentage of Participants |