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:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00770913
First received: October 9, 2008
Last updated: April 16, 2012
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.:

Primary Outcome Measures:
  • Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00770913     History of Changes
Other Study ID Numbers: E3810-J081-304
Study First Received: October 9, 2008
Results First Received: September 13, 2011
Last Updated: April 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
reflux esophagitis
rabeprazole
GERD
Japan

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 17, 2014