Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary: 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.
Sponsor: Eisai Co., Ltd.
Current Primary Outcome: Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) [ Time Frame: 8 weeks ]
Original Primary Outcome: Upper GI endoscopy (EGD) [ Time Frame: Every 4-8 weeks. ]
Current Secondary Outcome:
Original Secondary Outcome: Adverse events, lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin, etc.) [ Time Frame: Every 4-8 weeks. ]
Information By: Eisai Inc.
Dates:
Date Received: October 9, 2008
Date Started: October 2008
Date Completion:
Last Updated: April 16, 2012
Last Verified: June 2010
