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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007735
Receipt No. R000009112
Scientific Title Randomised comparison study: eradication therapy for Helicobacter pylori with or without ecabet sodium after endoscopic submucosal dissection (ESD) of early gastric cancer
Date of disclosure of the study information 2012/04/12
Last modified on 2012/04/12

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Basic information
Public title Randomised comparison study: eradication therapy for Helicobacter pylori with or without ecabet sodium after endoscopic submucosal dissection (ESD) of early gastric cancer
Acronym Quadruple eradication therapy with ecabet sodium of early gastric cancer after ESD.
Scientific Title Randomised comparison study: eradication therapy for Helicobacter pylori with or without ecabet sodium after endoscopic submucosal dissection (ESD) of early gastric cancer
Scientific Title:Acronym Quadruple eradication therapy with ecabet sodium of early gastric cancer after ESD.
Region
Japan

Condition
Condition H.pylori positive early gastric cancer patient who underwent an ESD.
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether quadruple therapy with ecabet sodium improve eradication rate for early gastric cancer after ESD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Eradication rate: 8 weeks after eradication therapy (12 weeks after ESD treatment)
Key secondary outcomes Ulcer healing : 8 weeks after ESD treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group: patients receive H.pylori eradication therapy (omeprazole 20 mg, amoxicillin 750mg, clarithromycin 200mg) twice a day for 1 week and then omeprazole (20mg once a day) for 4 weeks.
Interventions/Control_2 Treatment group: patients receive H.pylori eradication therapy (omeprazole 20 mg, amoxicillin 750mg, clarithromycin 200mg) with ecabet sodium 1g twice a day for 1 week and then omeprazole (20mg once a day) and ecabet sodium (1g twice a day) for 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The function of main organ(hearrt, lung, liver, kidney)is kept and the clinical inspection levels are within the following rules.
1.WBC:>=3000/mm3, <=12000/mm3
2.Hb:>=9.0g/dL
3.PLT:>=100,000/mm3
4.AST, ALT:<=100IU/L
5.T-Bil:<=2.0mg/dL
6.Serum CRE:<=1.5mg/dL
The sympton is slight even if complicated with other disease, and there is not problem to receive eradication therapy.
The patient provided written informed consents to participate in this study.
Key exclusion criteria 1 Patients with past H.pylori eradication therapy.
2. Patients with suspected gastrointestinal stenosis and diagnosed gastrointestinal stenosis.
3. Patients with a history of upper gastrointestinal tract ablative operation or the vagotomy.
4. Patients with the active overlap cancer except the gastric cancer.
5. Patients with severe liver, renal, cardiac or hematopoietic dysfunction.
6. Patients with hypersensitivity to ecabet sodium.
7. Pregnant or lactating women or women who intended to become pregnant during the study period.
8. Patients with a history of allergy to omeprazole, amoxicilline, clarithromycin, or penicilline.
9. Patients receiving atazanavir sulfate, pimozide, ergotamine component preparation, tadalafil(adcirca).
10. Patients with mononucleosis.
11. Inadequate to entry judged by investigator.
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanabe Satoshi
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara-shi, Kanagawa-Ken
TEL 042-748-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tanabe Satoshi
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara-shi, Kanagawa-Ken
TEL 042-748-9111
Homepage URL
Email s-tanabe@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北里大学東病院消化器内科(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 12 Day
Last modified on
2012 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009112

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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