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 is currently recruiting participants.

Verified by Eisai Inc., August 2009

First Received: October 9, 2008 Last Updated: August 26, 2009 History of Changes

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

Purpose

The purpose of this study is to evaluate the efficacy and safety of E3810 (Aciphex) 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Upper GI endoscopy (EGD) [ 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
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: E3810 20 mg, taken orally, once a day for 8 weeks.
2: Experimental	Drug: E3810 10 mg, taken orally, twice a day for 8 weeks.
3: Experimental	Drug: E3810 20 mg taken orally, twice a day for 8 weeks.

Detailed Description:

This is a multicenter, randomized, double-blinded study. The efficacy with E3810 (Aciphex) 20 mg once daily will be compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse events, 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 (PPI) 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 its treatment and screening is less than 12 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770913

Contacts

Contact: Customer Information Services Department. CRC and QA

_ML_CLNCL@hhc.eisai.co.jp

Show 41 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Tomoki Kubota

Development Clinical Research Dept., Clinical Research Center

More Information

No publications provided

Responsible Party:	Eisai Company Limited ( Customer Information Services Department. CRC and QA )
Study ID Numbers:	E3810-J081-304
Study First Received:	October 9, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00770913 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:

reflux esophagitis
rabeprazole
GERD
Japan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Esophagitis
Esophagitis, Peptic

Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Gastroenteritis
Peptic Ulcer
Rabeprazole

ClinicalTrials.gov processed this record on February 09, 2010