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

NCT ID: NCT00125736

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-01
• Study Completion Date: 2007-04-19

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).

Conditions

Stomach Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

E0671 combination group

Group Type: EXPERIMENTAL

E0671

Intervention Type: DRUG

One 50 mg capsule is orally administered three times daily (150 mg/day)

rabeprazole sodium

Intervention Type: DRUG

One 10mg tablet is administered orally each day

placebo combination group

Group Type: PLACEBO_COMPARATOR

rabeprazole sodium

Intervention Type: DRUG

One 10mg tablet is administered orally each day

E0671 placebo

Intervention Type: DRUG

One 50 mg capsule is orally administered three times daily (150 mg/day)

Interventions

E0671

One 50 mg capsule is orally administered three times daily (150 mg/day)

Intervention Type: DRUG

rabeprazole sodium

One 10mg tablet is administered orally each day

Intervention Type: DRUG

E0671 placebo

One 50 mg capsule is orally administered three times daily (150 mg/day)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toshihisa Arai

Role: STUDY_DIRECTOR

GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

Locations

Kariya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Seto, Aichi-ken, Japan

Toyoake, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Akita, Akira, Japan

Urayasu, Chiba, Japan

Niihama, Ehime, Japan

Chikushino-shi, Fukoka, Japan

Fukoka, Fukoka, Japan

Kurume, Fukoka, Japan

Oumuta, Fukoka, Japan

Tagawa, Fukoka, Japan

Sabae, Fukui, Japan

Hashima, Gifu, Japan

Asahikawa, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Miki, Hyōgo, Japan

Kanazawa, Ishikawa-ken, Japan

Kumamotoi, Kumamoto, Japan

Sendai, Miyagi, Japan

Kashihara, Nara, Japan

Nigata, Niigata, Japan

Yufu, Oita Prefecture, Japan

Ikeda, Osaka, Japan

Izumisano, Osaka, Japan

Kadoma, Osaka, Japan

Takatsuki, Osaka, Japan

Hasuda, Saitama, Japan

Kitaadachi-gun, Saitama, Japan

Matsue, Shimane, Japan

Hamamatsu, Shizouka, Japan

Minato-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjyuku-ku, Tokyo, Japan

Shimonoseki, Yamaguchi, Japan

Gifu, , Japan

Hiroshima, , Japan

Kouchi, , Japan

Kyoto, , Japan

Nara, , Japan

Ōita, , Japan

Saga, , Japan

Countries

Japan

Other Identifiers

E0671-J081-291

Identifier Type: -

Identifier Source: org_study_id