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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

Primary Purpose

Refractory Reflux Esophagitis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
E3810
E3810
E3810
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Reflux Esophagitis focused on measuring reflux esophagitis, rabeprazole, GERD, Japan

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2008
Last Updated
April 16, 2012
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00770913
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Reflux Esophagitis
Keywords
reflux esophagitis, rabeprazole, GERD, Japan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
E3810
Other Intervention Name(s)
Aciphex
Intervention Description
20 mg taken orally, once a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
E3810
Other Intervention Name(s)
Aciphex
Intervention Description
10 mg, taken orally, twice a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
E3810
Other Intervention Name(s)
Aciphex
Intervention Description
20 mg taken orally, twice a day for 8 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
Description
Grade N indicates a normal appearance of lower esophageal mucosa
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoki Kubota
Organizational Affiliation
New Product Development Dept., Clinical Research Center
Official's Role
Study Director
Facility Information:
City
Nagakute
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Abiko
State/Province
Chiba
Country
Japan
City
Kashiwa
State/Province
Chiba
Country
Japan
City
Yachiyo
State/Province
Chiba
Country
Japan
City
Chikushino
State/Province
Fukuoka
Country
Japan
City
Omuta
State/Province
Fukuoka
Country
Japan
City
Tagawa
State/Province
Fukuoka
Country
Japan
City
Koriyama
State/Province
Fukushima
Country
Japan
City
Hashima
State/Province
Gifu
Country
Japan
City
Maebashi
State/Province
Gunma
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Itami
State/Province
Hyogo
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Hitachi
State/Province
Ibaraki
Country
Japan
City
Takamatsu
State/Province
Kagawa
Country
Japan
City
Kirishima
State/Province
Kagoshima
Country
Japan
City
Kawasaki
State/Province
Kanagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Ishinomaki
State/Province
Miyagi
Country
Japan
City
Yamatokoriyama
State/Province
Nara
Country
Japan
City
Beppu
State/Province
Oita
Country
Japan
City
Hirakata
State/Province
Osaka
Country
Japan
City
Karatsu
State/Province
Saga
Country
Japan
City
Kusatsu
State/Province
Shiga
Country
Japan
City
Izumo
State/Province
Shimane
Country
Japan
City
Matsue
State/Province
Shimane
Country
Japan
City
Fujieda
State/Province
Shizuoka
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Shimada
State/Province
Shizuoka
Country
Japan
City
Ohtawara
State/Province
Tochigi
Country
Japan
City
Bunkyo
State/Province
Tokyo
Country
Japan
City
Itabashi
State/Province
Tokyo
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Shinagawa
State/Province
Tokyo
Country
Japan
City
Shinjuku
State/Province
Tokyo
Country
Japan
City
Hofu
State/Province
Yamaguchi
Country
Japan
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
City
Akita
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Kouchi
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Nagasaki
Country
Japan
City
Oita
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Saga
Country
Japan
City
Shizuoka
Country
Japan
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Learn more about this 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

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