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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008545
Receipt No. R000010036
Official scientific title of the study Effects of H. pylori eradication therapy on the cure of stomach ulcer after endoscopic submucosal dissection
Date of disclosure of the study information 2012/07/30
Last modified on 2017/01/28

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Basic information
Official scientific title of the study Effects of H. pylori eradication therapy on the cure of stomach ulcer after endoscopic submucosal dissection
Title of the study (Brief title) ESD-eradication study
Region
Japan

Condition
Condition post ESD ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of H. pylori eradication therapy before ESD on the cure of post ESD ulcer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The ratio of ulceration area after 1 month of ESD compared with that of right after ESD
Key secondary outcomes Cure rate of ulcers (4W, 8W after ESD)
H. pylori eradication rate
H. pylori infection rate
Background of the patients
Compliance of the medications

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Doing H. pylori eradication therapy before ESD
Interventions/Control_2 Not doing H. pylori eradication therapy before ESD
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients planned ESD due to early stomach cancer or suspicious of the cancer
Key exclusion criteria Patients without H. pylori infection
Patients with the history of gastric surgeries
Patients with alarm symptoms such as vomiting, GI bleeding, rapid body weight loss
Patients with alcohol/drug dependence
Patients with severe endocrine problems
Patients with severe injuries of heart, liver, kidney or bone marrow functions
Patients with allergy against the test drugs
Patients with pregnancy, possible pregnancy or breast feeding, or hope of pregnancy during the test period
Patients whom the doctor decide as not proper for the study
Target sample size 80

Research contact person
Name of lead principal investigator Masashi Matsushima
Organization Tokai University School of Medicine
Division name Internal Medicine (Gastroenterology)
Address 143 Shomokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Email mmatsush@tokai.ac.jp

Public contact
Name of contact person Masashi Matsushima
Organization Tokai University School of Medicine
Division name Internal Medicine (Gastroenterology)
Address 143 Shomokasuya, Isehara, Kanagawa, Japan
TEL 03-3370-2321
Homepage URL
Email mmatsush@tok.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東海大学東京病院(東京都) Tokai University Tokyo Hospital
東海大学医学部付属病院(神奈川県) Tokai University Hospital
東海大学八王子病院(東京都) Tokai University Hachioji Hospital
東海大学大磯病院(神奈川県) Tokai University Oiso Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 30 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 15 Day
Anticipated trial start date
2012 Year 07 Month 30 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2012 Year 07 Month 26 Day
Last modified on
2017 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010036


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