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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ClinicalTrials.gov Identifier: NCT00125736 |
Recruitment Status :
Completed
First Posted : August 2, 2005
Last Update Posted : October 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stomach Ulcer | Drug: E0671 Drug: rabeprazole sodium Drug: E0671 placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 520 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium |
Actual Study Start Date : | August 1, 2005 |
Actual Primary Completion Date : | April 19, 2007 |
Actual Study Completion Date : | April 19, 2007 |

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) |
- Ratio of S2-stage transition at 8 weeks after the study administration. [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients with gastric ulcer (A1-and A2-stage)
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125736
Japan | |
Kariya, Aichi, Japan | |
Nagoya, Aichi, Japan | |
Seto, Aichi, Japan | |
Toyoake, Aichi, Japan | |
Toyohashi, Aichi, Japan | |
Akita, Akira, Japan | |
Urayasu, Chiba, Japan | |
Niihama, Ehime, Japan | |
Chikushino, Fukoka, Japan | |
Kurume, Fukoka, Japan | |
Oumuta, Fukoka, Japan | |
Tagawa, Fukoka, Japan | |
Sabae, Fukui, Japan | |
Hashima, Gifu, Japan | |
Asahikawa, Hokkaido, Japan | |
Sapporo, Hokkaido, Japan | |
Miki, Hyogo, Japan | |
Kanazawa, Ishikawa, Japan | |
Kumamotoi, Kumamoto, Japan | |
Sendai, Miyagi-prefecture, Japan | |
Kashihara, Nara, Japan | |
Yufu, Oita, Japan | |
Ikeda, Osaka, Japan | |
Izumisano, Osaka, Japan | |
Kadoma, Osaka, Japan | |
Takatsuki, Osaka, Japan | |
Hasuda, Saitama, Japan | |
Kitaadachi-gun, Saitama, Japan | |
Matue, Shimane, Japan | |
Hamamatsu, Shizouka, Japan | |
Minato-ku, Tokyo, Japan | |
Shinagawa-ku, Tokyo, Japan | |
Shinjyuku-ku, Tokyo, Japan | |
Shimonoseki, Yamaguchi, Japan | |
Fukoka, Japan | |
Gifu, Japan | |
Hiroshima, Japan | |
Kouchi, Japan | |
Kyoto, Japan | |
Nara, Japan | |
Nigata, Japan | |
Oita, Japan | |
Saga, Japan |
Study Director: | Toshihisa Arai | GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center |
Responsible Party: | Eisai Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00125736 |
Other Study ID Numbers: |
E0671-J081-291 |
First Posted: | August 2, 2005 Key Record Dates |
Last Update Posted: | October 29, 2018 |
Last Verified: | January 2010 |
Stomach Ulcer Ulcer Pathologic Processes Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Stomach Diseases Rabeprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |