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| Sponsor: | Eisai Limited |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00125736 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stomach Ulcer |
Drug: Teprenone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 520 |
| Study Start Date: | August 2005 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.
Patients who meet any of the following conditions:
Exclusion criteria:
Contacts and 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 | |
| Study Director: | Toshihisa Arai | GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00125736 History of Changes |
| Other Study ID Numbers: | E0671-J081-291 |
| Study First Received: | July 29, 2005 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Stomach Ulcer Ulcer Peptic Ulcer Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Pathologic Processes Geranylgeranylacetone |
Rabeprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |