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Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01264822
First received: December 20, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
Drug: Rabeprazole Sodium
Phase 4

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 2015 (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

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

Contacts
Contact: Customer & Product Quality Infomation Center _ML_CLNCL@hhc.eisai.co.jp

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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01264822     History of Changes
Other Study ID Numbers: PRT10T
Study First Received: December 20, 2010
Last Updated: October 11, 2012
Health Authority: Japan:Helth, Labour and Welfare Ministry

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

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

ClinicalTrials.gov processed this record on November 20, 2014