UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007735 |
|---|---|
| Receipt number | 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 21:59:41 |
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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
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
s-tanabe@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009112
