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

Refractory Reflux Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770913
• Other study ID #: E3810-J081-304
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 9, 2008
• Last updated: April 16, 2012
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Refractory Reflux Esophagitis

Intervention

Drug:
• E3810
20 mg taken orally, once a day for 8 weeks.
• E3810
10 mg, taken orally, twice a day for 8 weeks.
• E3810
20 mg taken orally, twice a day for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)	Grade N indicates a normal appearance of lower esophageal mucosa	8 weeks	No