Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

NCT01264822 | Completed

• 1 other identifier: PRT10T
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 42

Brief Summary

To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori

Conditions

Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive

Keywords

Rabeprazole Sodium; Helicobacter pylori; stomach neoplasms

Outcome Measures

Primary Outcomes (2)

• Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori

  Every 3 months within the 1st year and every 6 months

• Transition rate to secondary therapy for eradication of Helicobacter pylori

  Every 6 months within the 1st year and every 12 months as needed

Study Arms (1)

Treatment Arm 1 Rabeprazole Sodium

Drug: Rabeprazole Sodium

Interventions

Rabeprazole Sodium DRUG

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.

Treatment Arm 1 Rabeprazole Sodium

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitals and Clinics in Japan

You may qualify if:

• gastric low-grade mucosa-associated lymphoid tissue (MALT) lymphoma with Helicobacter pylori positive
• The stages of MALT lymphoma are Lugano International Conference classification Stage I or II 1 and Wotherspoon grade 4 or 5

You may not qualify if:

• With diffuse large B-cell lymphoma
• Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
• Corresponding to contraindication of each drug

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (42)

Unknown Facility

Nagoya, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Fukuyama, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Hitachi, Ibaraki, Japan

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Takamatsu, Kagawa-ken, Japan

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Isehara, Kanagawa, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Nagano, Nagano, Japan

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Suzaka, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Nara, Nara, Japan

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Niigata, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Yufu, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Tsuyama, Okayama-ken, Japan

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Hirakata, Osaka, Japan

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Osaka, Osaka, Japan

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Sayama, Osaka, Japan

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Takatsuki, Osaka, Japan

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Saga, Saga-ken, Japan

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Matsue, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Otawara-shi, Tochigi, Japan

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Chūō, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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tabashi City, Tokyo, Japan

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Tottori-shi, Tottori, Japan

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Toyama, Toyama, Japan

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Yamagata, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Yamaguchi, Yamaguchi, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Katsuya Sugizaki

  Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: January 13, 2011
• Primary Completion: February 29, 2016
• Study Completion: November 17, 2016
• Last Updated: February 27, 2017

Record last verified: 2017-01

Locations

JP (42)