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Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264822
First Posted: December 22, 2010
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori

Condition Intervention
Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive Drug: Rabeprazole Sodium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori [ Time Frame: Every 3 months within the 1st year and every 6 months ]
  • Transition rate to secondary therapy for eradication of Helicobacter pylori [ Time Frame: Every 6 months within the 1st year and every 12 months as needed ]

Enrollment: 108
Actual Study Start Date: January 13, 2011
Study Completion Date: November 17, 2016
Primary Completion Date: February 29, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Arm 1 Rabeprazole Sodium Drug: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitals and Clinics in Japan
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • With diffuse large B-cell lymphoma
  • Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
  • Corresponding to contraindication of each drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264822


Locations
Japan
Nagoya, Aichi, Japan
Hirosaki, Aomori, Japan
Kashiwa, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuyama, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Amagasaki-shi, Hyogo, Japan
Kobe, Hyogo, Japan
Hitachi, Ibaraki, Japan
Takamatsu, Kagawa, Japan
Isehara, Kanagawa, Japan
Sendai, Miyagi, Japan
Nagano-shi, Nagano, Japan
Suzaka, Nagano, Japan
Oita-shi, Oita, Japan
Yufu, Oita, Japan
Kurashiki, Okayama, Japan
Tsuyama, Okayama, Japan
Hirakata, Osaka, Japan
Osakasayama, Osaka, Japan
Takatsuki, Osaka, Japan
Matsue, Shimane, Japan
Hamamatsu, Shizuoka, Japan
Otawara-shi, Tochigi, Japan
Chuo, Tokyo, Japan
Itabashi, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Yamagata-shi, Yamagata, Japan
Ube, Yamaguchi, Japan
Fukuoka, Japan
Hiroshima, Japan
Kyoto, Japan
Nagasaki, Japan
Nara, Japan
Niigata, Japan
Okayama, Japan
Osaka, Japan
Saga, Japan
Tottori, Japan
Toyama, Japan
Yamaguchi, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Katsuya Sugizaki Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01264822     History of Changes
Other Study ID Numbers: PRT10T
First Submitted: December 20, 2010
First Posted: December 22, 2010
Last Update Posted: February 27, 2017
Last Verified: January 2017

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Rabeprazole Sodium
Helicobacter pylori
stomach neoplasms

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Stomach Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action