Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
- Registration Number
- NCT00770913
- Lead Sponsor
- Eisai Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 E3810 - 3 E3810 - 1 E3810 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method