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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E0671 combination group | Experimental |
| |
| placebo combination group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E0671 | Drug | One 50 mg capsule is orally administered three times daily (150 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of S2-stage transition at 8 weeks after the study administration. | 8 weeks |
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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.
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:
Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshihisa Arai | GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kariya | Aichi-ken | Japan | ||||
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| rabeprazole sodium | Drug | One 10mg tablet is administered orally each day |
|
| E0671 placebo | Drug | One 50 mg capsule is orally administered three times daily (150 mg/day) |
|
| 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 |
| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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