We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770913
First Posted: October 10, 2008
Last Update Posted: April 18, 2012
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.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
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 Intervention Phase
Refractory Reflux Esophagitis Drug: E3810 Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome 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


Enrollment: 337
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00770913     History of Changes
Other Study ID Numbers: E3810-J081-304
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: September 13, 2011
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