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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00770913
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : April 13, 2012
Last Update Posted : April 18, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Refractory Reflux Esophagitis Drug: E3810 Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2008
Primary Completion Date : November 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Rabeprazole
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770913


  Show 54 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tomoki Kubota New Product Development Dept., Clinical Research Center

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00770913     History of Changes
Other Study ID Numbers: E3810-J081-304
First Posted: October 10, 2008    Key Record Dates
Results First Posted: April 13, 2012
Last Update Posted: April 18, 2012
Last Verified: June 2010

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
reflux esophagitis
rabeprazole
GERD
Japan

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action