To investigate the efficacy and safety of E0671 combination therapy (10 mg/day of rabeprazole sodium and 150 mg/day of E0671) 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).

Condition	Intervention	Phase
Stomach Ulcer	Drug: Teprenone	Phase IV

Further Study Details: 

Primary Outcomes: Ratio of S2-stage transition at 8 weeks after the study administration.
Secondary Outcomes: a) Endoscopic finding: Ratio of S2-stage transition at 4 weeks after the study administration (or at discontinuation), and healing rate of ulcer at 4 and 8 weeks after the study administration (or at discontinuation).; b) Subjective finding due to gastric ulcer: healing rate/disappearance rates of subjective finding at 4 and 8 weeks after the study drug administration (or at discontinuation).; c) Gastric mucosal histopathology: degree of neutrophil infiltration at 8 weeks after the study administration (or at discontinuation).
Expected Total Enrollment:  520

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

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.

1) Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).

2) Patients who are not younger than 20 years of age at the time of obtaining informed consent.

3) 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:

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 endosopy.

7) Patients who underwent gastrectomy or vergal 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 present or history of drug allergy to teprenone preparation(s).

12) Patients with a present or 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125736

Customer Information Services Department. CRC & QA       ML_CLNCL@hhc.eisai.co.jp

Japan, Miyagi-prefecture
      Sendai,  Miyagi-prefecture,  982-8501,  Japan

Study chairs or principal investigators

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

Study ID Numbers:  E0671-J081-291
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125736
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-02