UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030270 |
|---|---|
| Receipt number | R000026664 |
| Scientific Title | Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents |
| Date of disclosure of the study information | 2017/12/05 |
| Last modified on | 2017/12/05 15:05:13 |
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Basic information
Public title
Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents
Acronym
Efficacy of tailored HP eradication based on susceptibility to antimicrobial agents
Scientific Title
Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents
Scientific Title:Acronym
Efficacy of tailored HP eradication based on susceptibility to antimicrobial agents
Region
| Japan |
Condition
Condition
H. pylori-associated gastritis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of tailored eradication therapy based on susceptibility to antimicrobial agents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of tailored eradication therapy based on susceptibility to antimicrobial agents.
Key secondary outcomes
1. Eradication rate of tailored tailored H. pylori eradication therapy based on susceptibility to antimicrobial agents among different CYP2C19, CYP3A4, CYP3A5 genotypes.
2.Change of abdominal symptoms between before and after eradication therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conventional:7 days
VPZ20mg/AMPC750mg/CAM200mg bid
Interventions/Control_2
Tailored: 7 days
1. CAM-S: VPZ20mg/AMPC750mg/CAM200mg bid
2. CAM-R: VPZ20mg/AMPC750mg/MNZ250mg bid
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age; mere than 20 years
2. With informed consent
3. Positive for culture test of H. pylori
Key exclusion criteria
1. With malignant diseases
2. Negative for culture test
3. With severe liver disease
4. No informed consent
5. Not suitable by judgement of Medical Doctor
Target sample size
310
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
Organization
Shiga University of Medical Science Hospital
Division name
Division of Digestive Endoscopy
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2618
sugimo@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
Organization
Shiga University of Medical Science Hospital
Division name
Division of Digestive Endoscopy
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2618
Homepage URL
sugimo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 05 | 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
| 2016 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | 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
| 2017 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026664
