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A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

Primary Purpose

Stomach Ulcer

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
E0671
rabeprazole sodium
E0671 placebo
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients with gastric ulcer (A1-and A2-stage) Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked. Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification). Patients who are not younger than 20 years of age at the time of obtaining informed consent. Patients who meet any of the following conditions: H. pylori-negative H. pylori-positive and not requiring eradication therapy H. pylori-positive and unsuccessful eradication Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation. Exclusion criteria: Patients with a complication of duodenal ulcer (excluding cicatrix). Patients with reflux esophagitis Patients with acute gastric mucosal lesions (AGML). Patients with NSAID-induced ulcer. Patients with linear ulcer. Patients with ulcer injured by endoscopy. Patients who underwent gastrectomy or vagal nerve resection. Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc. Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration. Patients with serious cardiovascular diseases (e.g., angina pectoris, heart failure, acute myocardial ischemia, severe tachyarrhythmia), serious hematological disorders (e.g., aplastic anemia), serious renal disorders (e.g., acute, chronic renal failure), serious hepatic disorders (e.g., cirrhosis, severe hepatitis), serious pancreatic disorders (e.g., severe pancreatitis), serious psychoneuroses (e.g., schizophrenia, alcoholic dependency, drug dependency, severe depression), or cancer. Patients with a current or a history of drug allergy to teprenone preparation(s). Patients with a current or a history of drug allergy to PPI. Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E0671 combination group

placebo combination group

Arm Description

Outcomes

Primary Outcome Measures

Ratio of S2-stage transition at 8 weeks after the study administration.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2005
Last Updated
October 26, 2018
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00125736
Brief Title
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
Official Title
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 1, 2005 (Actual)
Primary Completion Date
April 19, 2007 (Actual)
Study Completion Date
April 19, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
Detailed Description
The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E0671 combination group
Arm Type
Experimental
Arm Title
placebo combination group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E0671
Intervention Description
One 50 mg capsule is orally administered three times daily (150 mg/day)
Intervention Type
Drug
Intervention Name(s)
rabeprazole sodium
Intervention Description
One 10mg tablet is administered orally each day
Intervention Type
Drug
Intervention Name(s)
E0671 placebo
Intervention Description
One 50 mg capsule is orally administered three times daily (150 mg/day)
Primary Outcome Measure Information:
Title
Ratio of S2-stage transition at 8 weeks after the study administration.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with gastric ulcer (A1-and A2-stage) Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked. Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification). Patients who are not younger than 20 years of age at the time of obtaining informed consent. Patients who meet any of the following conditions: H. pylori-negative H. pylori-positive and not requiring eradication therapy H. pylori-positive and unsuccessful eradication Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation. Exclusion criteria: Patients with a complication of duodenal ulcer (excluding cicatrix). Patients with reflux esophagitis Patients with acute gastric mucosal lesions (AGML). Patients with NSAID-induced ulcer. Patients with linear ulcer. Patients with ulcer injured by endoscopy. Patients who underwent gastrectomy or vagal nerve resection. Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc. Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration. Patients with serious cardiovascular diseases (e.g., angina pectoris, heart failure, acute myocardial ischemia, severe tachyarrhythmia), serious hematological disorders (e.g., aplastic anemia), serious renal disorders (e.g., acute, chronic renal failure), serious hepatic disorders (e.g., cirrhosis, severe hepatitis), serious pancreatic disorders (e.g., severe pancreatitis), serious psychoneuroses (e.g., schizophrenia, alcoholic dependency, drug dependency, severe depression), or cancer. Patients with a current or a history of drug allergy to teprenone preparation(s). Patients with a current or a history of drug allergy to PPI. Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshihisa Arai
Organizational Affiliation
GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center
Official's Role
Study Director
Facility Information:
City
Kariya
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Seto
State/Province
Aichi
Country
Japan
City
Toyoake
State/Province
Aichi
Country
Japan
City
Toyohashi
State/Province
Aichi
Country
Japan
City
Akita
State/Province
Akira
Country
Japan
City
Urayasu
State/Province
Chiba
Country
Japan
City
Niihama
State/Province
Ehime
Country
Japan
City
Chikushino
State/Province
Fukoka
Country
Japan
City
Kurume
State/Province
Fukoka
Country
Japan
City
Oumuta
State/Province
Fukoka
Country
Japan
City
Tagawa
State/Province
Fukoka
Country
Japan
City
Sabae
State/Province
Fukui
Country
Japan
City
Hashima
State/Province
Gifu
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Miki
State/Province
Hyogo
Country
Japan
City
Kanazawa
State/Province
Ishikawa
Country
Japan
City
Kumamotoi
State/Province
Kumamoto
Country
Japan
City
Sendai
State/Province
Miyagi-prefecture
Country
Japan
City
Kashihara
State/Province
Nara
Country
Japan
City
Yufu
State/Province
Oita
Country
Japan
City
Ikeda
State/Province
Osaka
Country
Japan
City
Izumisano
State/Province
Osaka
Country
Japan
City
Kadoma
State/Province
Osaka
Country
Japan
City
Takatsuki
State/Province
Osaka
Country
Japan
City
Hasuda
State/Province
Saitama
Country
Japan
City
Kitaadachi-gun
State/Province
Saitama
Country
Japan
City
Matue
State/Province
Shimane
Country
Japan
City
Hamamatsu
State/Province
Shizouka
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Shinjyuku-ku
State/Province
Tokyo
Country
Japan
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
City
Fukoka
Country
Japan
City
Gifu
Country
Japan
City
Hiroshima
Country
Japan
City
Kouchi
Country
Japan
City
Kyoto
Country
Japan
City
Nara
Country
Japan
City
Nigata
Country
Japan
City
Oita
Country
Japan
City
Saga
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

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