Conditions: Refractory Reflux Esophagitis
Keywords: reflux esophagitis rabeprazole GERD Japan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 337
Healthy volunteers: no

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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: E3810 intervention 2: E3810 intervention 3: E3810
Intervention descriptions: intervention 1: 20 mg taken orally, once a day for 8 weeks. intervention 2: 10 mg, taken orally, twice a day for 8 weeks. intervention 3: 20 mg taken orally, twice a day for 8 weeks.

Protocol document: