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 purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

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Key information

Conditions

Refractory Reflux Esophagitis Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Esophagitis, Peptic Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nagakute, Aichi-ken, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E3810

Drug

20 mg taken orally, once a day for 8 weeks.

Other names: Aciphex

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Oct 10, 2008
Registry last updated: Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed