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

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.

Study Overview

• Status: Completed
• Conditions: Stomach Ulcer
• Intervention / Treatment: Drug: E0671; Drug: rabeprazole sodium; Drug: E0671 placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukoka, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Kouchi, Japan
  • Kyoto, Japan
  • Nara, Japan
  • Nigata, Japan
  • Oita, Japan
  • Saga, Japan
  • Aichi
    • Kariya, Aichi, Japan
    • Nagoya, Aichi, Japan
    • Seto, Aichi, Japan
    • Toyoake, Aichi, Japan
    • Toyohashi, Aichi, Japan
  • Akira
    • Akita, Akira, Japan
  • Chiba
    • Urayasu, Chiba, Japan
  • Ehime
    • Niihama, Ehime, Japan
  • Fukoka
    • Chikushino, Fukoka, Japan
    • Kurume, Fukoka, Japan
    • Oumuta, Fukoka, Japan
    • Tagawa, Fukoka, Japan
  • Fukui
    • Sabae, Fukui, Japan
  • Gifu
    • Hashima, Gifu, Japan
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
    • Sapporo, Hokkaido, Japan
  • Hyogo
    • Miki, Hyogo, Japan
  • Ishikawa
    • Kanazawa, Ishikawa, Japan
  • Kumamoto
    • Kumamotoi, Kumamoto, Japan
  • Miyagi-prefecture
    • Sendai, Miyagi-prefecture, Japan
  • Nara
    • Kashihara, Nara, Japan
  • Oita
    • Yufu, Oita, Japan
  • Osaka
    • Ikeda, Osaka, Japan
    • Izumisano, Osaka, Japan
    • Kadoma, Osaka, Japan
    • Takatsuki, Osaka, Japan
  • Saitama
    • Hasuda, Saitama, Japan
    • Kitaadachi-gun, Saitama, Japan
  • Shimane
    • Matue, Shimane, Japan
  • Shizouka
    • Hamamatsu, Shizouka, Japan
  • Tokyo
    • Minato-ku, Tokyo, Japan
    • Shinagawa-ku, Tokyo, Japan
    • Shinjyuku-ku, Tokyo, Japan
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patients with gastric ulcer (A1-and A2-stage)

2. 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
3. Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.

Exclusion criteria:

1. Patients with a complication of duodenal ulcer (excluding cicatrix).
2. Patients with reflux esophagitis
3. Patients with acute gastric mucosal lesions (AGML).
4. Patients with NSAID-induced ulcer.
5. Patients with linear ulcer.
6. Patients with ulcer injured by endoscopy.
7. Patients who underwent gastrectomy or vagal nerve resection.
8. Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc.
9. Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration.
10. 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.
11. Patients with a current or a history of drug allergy to teprenone preparation(s).
12. Patients with a current or a history of drug allergy to PPI.
13. Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E0671 combination group	Drug: E0671; One 50 mg capsule is orally administered three times daily (150 mg/day); Drug: rabeprazole sodium; One 10mg tablet is administered orally each day
Placebo Comparator: placebo combination group	Drug: rabeprazole sodium; One 10mg tablet is administered orally each day; Drug: E0671 placebo; One 50 mg capsule is orally administered three times daily (150 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of S2-stage transition at 8 weeks after the study administration.	8 weeks

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Toshihisa Arai, GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2005
• Primary Completion (Actual): April 19, 2007
• Study Completion (Actual): April 19, 2007

Study Registration Dates

• First Submitted: July 29, 2005
• First Submitted That Met QC Criteria: July 29, 2005
• First Posted (Estimate): August 2, 2005

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E0671-J081-291