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 - Full Text View

Sponsor:	Eisai Limited
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00770913

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 II Phase III

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:

MedlinePlus related topics: GERD

Drug Information available for: Rabeprazole sodium

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Upper gastrointestinal endoscopy. [ Time Frame: Every 4-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, lab evaluations (hematology, blood chemistry, urinalysis, serum gastrin, etc.) [ Time Frame: Every 4-8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
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 53 Study Locations

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:

Tomoki Kubota

New Product Development Dept., Clinical Research Center

More Information

No publications provided

Responsible Party:	Tomoki Kubota, Department of New Product Development
ClinicalTrials.gov Identifier:	NCT00770913 History of Changes
Other Study ID Numbers:	E3810-J081-304
Study First Received:	October 9, 2008
Last Updated:	June 1, 2010
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
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012