Gastric Low-grade MALT Lymphoma With Helicobacter Pylori PositiveNCT01264822
Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
An observational study of Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive, run by Eisai Co., Ltd. at 42 sites in Japan.
Trial summary
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive
- What is being tested?
- Rabeprazole Sodium
- Type of treatment
- Pill or oral medicine
- How many people
- 108 participants
- Where
- 42 sitesJapan
- Study dates
- 13 Jan 2011to 17 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitals and Clinics in Japan
Who may be able to join
- 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
Who cannot join
- With diffuse large B-cell lymphoma
- Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
- Corresponding to contraindication of each drug
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Japan42 sites
Study site
Amagasaki-shi, Hyōgo
Study site
Chūō, Tokyo
Study site
Fukuoka, Fukuoka
Study site
Fukuyama, Hiroshima
Study site
Hamamatsu, Shizuoka
Study site
Hirakata, Osaka
Study site
Hirosaki, Aomori
Study site
Hiroshima, Hiroshima
Study site
Hitachi, Ibaraki
Study site
Isehara, Kanagawa
Study site
Kashiwa, Chiba
Study site
Kobe, Hyōgo
Study site
Kurashiki, Okayama-ken
Study site
Kyoto, Kyoto
Study site
Matsue, Shimane
Study site
Matsuyama, Ehime
Study site
Minato-ku, Tokyo
Study site
Nagano, Nagano
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Nara, Nara
Study site
Niigata, Niigata
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okayama-ken
Study site
Osaka, Osaka
Study site
Otawara-shi, Tochigi
Study site
Saga, Saga-ken
Study site
Sapporo, Hokkaido
Study site
Sayama, Osaka
Study site
Sendai, Miyagi
Study site
Shinagawa-ku, Tokyo
Study site
Suzaka, Nagano
Study site
tabashi City, Tokyo
Study site
Takamatsu, Kagawa-ken
Study site
Takatsuki, Osaka
Study site
Tottori-shi, Tottori
Study site
Toyama, Toyama
Study site
Tsuyama, Okayama-ken
Study site
Ube, Yamaguchi
Study site
Yamagata, Yamagata
Study site
Yamaguchi, Yamaguchi
Study site
Yufu, Oita Prefecture
About this study
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori
- Being tested
- Rabeprazole Sodium
- Keywords
- Rabeprazole Sodium, Helicobacter pylori, stomach neoplasms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole SodiumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 Rabeprazole Sodium | Not described Receives: Drug: Rabeprazole Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of gastric low-grade MALT lymphoma by eradication of Helicobacter pylori
Measured: Every 3 months within the 1st year and every 6 months
Transition rate to secondary therapy for eradication of Helicobacter pylori
Measured: Every 6 months within the 1st year and every 12 months as needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study start13 Jan 2011
- Primary completion29 Feb 2016
- Study completion17 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Low-grade MALT Lymphoma With Helicobacter Pylori PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuya Sugizaki, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264822
- Sponsor's protocol ID
- PRT10T
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2010
- Last updated
- 27 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Study of Gastric MALT Lymphoma After Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01264822
- Acronym / sponsor ID
- PRT10T
- Keywords
- Rabeprazole Sodium, Helicobacter pylori, stomach neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2011 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 17 Nov 2016 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To survey the grade of gastric MALT lymphoma after eradication of Helicobacter pylori
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 Rabeprazole Sodium | – | Drug: Rabeprazole Sodium |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals and Clinics in Japan
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- With diffuse large B-cell lymphoma
- Have been treated to gastric mucosa-associated lymphoid tissue (MALT) lymphoma
- Corresponding to contraindication of each drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabeprazole SodiumThe 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. | Drug | Treatment Arm 1 Rabeprazole Sodium |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katsuya Sugizaki study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Low-grade MALT Lymphoma With Helicobacter Pylori Positive, run by Eisai Co., Ltd. at 42 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.