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Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01264822
First received: December 20, 2010
Last updated: May 13, 2015
Last verified: May 2015
  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.:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 20, 2010
Last Updated: May 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Rabeprazole Sodium
Helicobacter pylori
stomach neoplasms

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

ClinicalTrials.gov processed this record on September 28, 2016