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

April 16, 2012 updated by: Eisai Co., Ltd.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan
      • Fukuoka, Japan
      • Gifu, Japan
      • Hiroshima, Japan
      • Kagoshima, Japan
      • Kouchi, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Nagasaki, Japan
      • Oita, Japan
      • Okayama, Japan
      • Osaka, Japan
      • Saga, Japan
      • Shizuoka, Japan
      • Yamagata, Japan
    • Aichi
      • Nagakute, Aichi, Japan
      • Nagoya, Aichi, Japan
    • Chiba
      • Abiko, Chiba, Japan
      • Kashiwa, Chiba, Japan
      • Yachiyo, Chiba, Japan
    • Fukuoka
      • Chikushino, Fukuoka, Japan
      • Omuta, Fukuoka, Japan
      • Tagawa, Fukuoka, Japan
    • Fukushima
      • Koriyama, Fukushima, Japan
    • Gifu
      • Hashima, Gifu, Japan
    • Gunma
      • Maebashi, Gunma, Japan
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
      • Sapporo, Hokkaido, Japan
    • Hyogo
      • Itami, Hyogo, Japan
      • Nishinomiya, Hyogo, Japan
    • Ibaraki
      • Hitachi, Ibaraki, Japan
    • Kagawa
      • Takamatsu, Kagawa, Japan
    • Kagoshima
      • Kirishima, Kagoshima, Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
      • Yokohama, Kanagawa, Japan
    • Miyagi
      • Ishinomaki, Miyagi, Japan
    • Nara
      • Yamatokoriyama, Nara, Japan
    • Oita
      • Beppu, Oita, Japan
    • Osaka
      • Hirakata, Osaka, Japan
    • Saga
      • Karatsu, Saga, Japan
    • Shiga
      • Kusatsu, Shiga, Japan
    • Shimane
      • Izumo, Shimane, Japan
      • Matsue, Shimane, Japan
    • Shizuoka
      • Fujieda, Shizuoka, Japan
      • Hamamatsu, Shizuoka, Japan
      • Shimada, Shizuoka, Japan
    • Tochigi
      • Ohtawara, Tochigi, Japan
    • Tokyo
      • Bunkyo, Tokyo, Japan
      • Itabashi, Tokyo, Japan
      • Setagaya, Tokyo, Japan
      • Shinagawa, Tokyo, Japan
      • Shinjuku, Tokyo, Japan
    • Yamaguchi
      • Hofu, Yamaguchi, Japan
      • Shimonoseki, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: E3810
20 mg taken orally, once a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
10 mg, taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
20 mg taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex
Experimental: 3
Drug: E3810
20 mg taken orally, once a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
10 mg, taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
20 mg taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex
Active Comparator: 1
Drug: E3810
20 mg taken orally, once a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
10 mg, taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex
Drug: E3810
20 mg taken orally, twice a day for 8 weeks.
Other Names:
  • Aciphex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Tomoki Kubota, New Product Development Dept., Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3810-J081-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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