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

Overview

The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2009

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

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Experimental: 2
  • Experimental: 3

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
    • Time Frame: 8 weeks
    • Grade N indicates a normal appearance of lower esophageal mucosa

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tomoki Kubota, Study Director, New Product Development Dept., Clinical Research Center

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