NCT00770913

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Reflux Esophagitis

Interventions

Type	Name	Description
DRUG	E3810	20 mg taken orally, once a day for 8 weeks.
DRUG	E3810	10 mg, taken orally, twice a day for 8 weeks.
DRUG	E3810	20 mg taken orally, twice a day for 8 weeks.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-11-01
• Completion: 2010-03-01
• First posted: 2008-10-10
• Last updated: 2012-04-18
• Results posted: 2012-04-13

Locations

54 sites across 1 country: Japan