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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Stomach Ulcer	Drug: Teprenone	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
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
Study Start Date :	August 2005
Actual Primary Completion Date :	September 2008

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

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, 982-8501
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

Sponsors and Collaborators

Eisai Limited

Investigators

Study Director:	Toshihisa Arai	GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00125736 History of Changes
Other Study ID Numbers:	E0671-J081-291
First Posted:	August 2, 2005
Last Update Posted:	January 29, 2010
Last Verified:	January 2010

Additional relevant MeSH terms:

Ulcer; Stomach 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