Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
NCT ID: NCT01264822
Last Updated: 2017-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2011-01-13
2016-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Arm 1 Rabeprazole Sodium
Rabeprazole Sodium
The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg.
The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily.
If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg.
Interventions
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Rabeprazole Sodium
The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg.
The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily.
If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg.
Eligibility Criteria
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Inclusion Criteria
* The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5
Exclusion Criteria
* Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
* Corresponding to contraindication of each drug
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Katsuya Sugizaki
Role: STUDY_DIRECTOR
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Locations
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Nagoya, Aichi-ken, Japan
Hirosaki, Aomori, Japan
Kashiwa, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuyama, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Amagasaki-shi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Hitachi, Ibaraki, Japan
Takamatsu, Kagawa-ken, Japan
Isehara, Kanagawa, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Nagano, Nagano, Japan
Suzaka, Nagano, Japan
Nagasaki, Nagasaki, Japan
Nara, Nara, Japan
Niigata, Niigata, Japan
Ōita, Oita Prefecture, Japan
Yufu, Oita Prefecture, Japan
Kurashiki, Okayama-ken, Japan
Okayama, Okayama-ken, Japan
Tsuyama, Okayama-ken, Japan
Hirakata, Osaka, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Takatsuki, Osaka, Japan
Saga, Saga-ken, Japan
Matsue, Shimane, Japan
Hamamatsu, Shizuoka, Japan
Otawara-shi, Tochigi, Japan
Chūō, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
tabashi City, Tokyo, Japan
Tottori-shi, Tottori, Japan
Toyama, Toyama, Japan
Yamagata, Yamagata, Japan
Ube, Yamaguchi, Japan
Yamaguchi, Yamaguchi, Japan
Countries
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Other Identifiers
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PRT10T
Identifier Type: -
Identifier Source: org_study_id
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