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

Condition(s) targeted: Stomach Ulcer

Intervention: Teprenone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Toshihisa Arai, Study Director, Affiliation: GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center

Overall contact:
Customer Information Services Department. CRC and QA, Email: ML_CLNCL@hhc.eisai.co.jp

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).

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Primary outcome: Ratio of S2-stage transition at 8 weeks after the study administration.

Secondary outcome:

Endoscopic finding: Ratio of S2-stage transition at 4 weeks after the study administration (or at discontinuation),

and healing rate of ulcer (S1+S2-stage) at 4 and 8 weeks after the study administration (or at discontinuation).

Subjective finding

Minimum age: 20 Years. Maximum age: N/A. Gender(s): 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:

1. H. pylori-negative

2. H. pylori-positive and not requiring eradication therapy

3. H. pylori-positive and unsuccessful eradication

4. 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.

Customer Information Services Department. CRC and QA, Email: ML_CLNCL@hhc.eisai.co.jp

Fukoka, Japan; Recruiting

Gifu, Japan; Recruiting

Hiroshima, Japan; Recruiting

Kouchi, Japan; Recruiting

Kyoto, Japan; Recruiting

Nara, Japan; Recruiting

Nigata, Japan; Recruiting

Oita, Japan; Recruiting

Saga, Japan; Recruiting

Toyohashi, Aichi, Japan; Recruiting

Toyoake, Aichi, Japan; Recruiting

Nagoya, Aichi, Japan; Recruiting

Seto, Aichi, Japan; Recruiting

Kariya, Aichi, Japan; Recruiting

Akita, Akira, Japan; Recruiting

Urayasu, Chiba, Japan; Recruiting

Niihama, Ehime, Japan; Recruiting

Chikushino, Fukoka, Japan; Recruiting

Oumuta, Fukoka, Japan; Recruiting

Tagawa, Fukoka, Japan; Recruiting

Kurume, Fukoka, Japan; Recruiting

Sabae, Fukui, Japan; Recruiting

Hashima, Gifu, Japan; Recruiting

Asahikawa, Hokkaido, Japan; Recruiting

Sapporo, Hokkaido, Japan; Recruiting

Miki, Hyogo, Japan; Recruiting

Kanazawa, Ishikawa, Japan; Recruiting

Kumamotoi, Kumamoto, Japan; Recruiting

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

Kashihara, Nara, Japan; Recruiting

Yufu, Oita, Japan; Recruiting

Kadoma, Osaka, Japan; Recruiting

Izumisano, Osaka, Japan; Recruiting

Ikeda, Osaka, Japan; Recruiting

Takatsuki, Osaka, Japan; Recruiting

Hasuda, Saitama, Japan; Recruiting

Kitaadachi-gun, Saitama, Japan; Recruiting

Matue, Shimane, Japan; Recruiting

Hamamatsu, Shizouka, Japan; Recruiting

Shinjyuku-ku, Tokyo, Japan; Recruiting

Shinagawa-ku, Tokyo, Japan; Recruiting

Minato-ku, Tokyo, Japan; Recruiting

Shimonoseki, Yamaguchi, Japan; Recruiting

Starting date: August 2005
Last updated: March 21, 2007