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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014910
Receipt No. R000017335
Scientific Title Study of optimization of Helicobacter pylori eradication therapy in consideration of the PK / PD in chronic hemodialysis patients
Date of disclosure of the study information 2014/09/15
Last modified on 2016/02/16

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Basic information
Public title Study of optimization of Helicobacter pylori eradication therapy in consideration of the PK / PD in chronic hemodialysis patients
Acronym Eradication therapy of Helicobacter pyroli in dialysis patients
Scientific Title Study of optimization of Helicobacter pylori eradication therapy in consideration of the PK / PD in chronic hemodialysis patients
Scientific Title:Acronym Eradication therapy of Helicobacter pyroli in dialysis patients
Region
Japan

Condition
Condition Helicobacter pylori-associated chronic gastritis
Classification by specialty
Gastroenterology Nephrology Infectious disease
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In the present study, we will set up the Proton Pump Inhibitor (PPI) regimen exhibits sufficient acid secretion inhibitory effect irrespective of CYP2C19 genotypes which participate in the metabolism of PPI and establish the optimal Helicobacter pylori eradication therapy by taking the presence of resistance to antibiotics into consideration for dialysis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of eradication therapy
Safety of eradication therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 standard eradication therapy
PPI bid+AMPC(750) bid+CAM(200) bid
for a week
Interventions/Control_2 low-dose amoxicillin therapy
PPI bid+AMPC(250) bid+CAM(200) bid
for a week
Interventions/Control_3 Individualized therapy
CAM-sensitive Helicobacter pylori strain:
PPI qid+AMPC(250) bid+CAM(200) bid
for a week
CAM-resistant Helicobacer pylori strain:
PPI qid+AMPC(250) bid+MNZ(250) bid
for a week
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
90 years-old >
Gender Male and Female
Key inclusion criteria Helicobacter pylori-associated gastritis
Key exclusion criteria subjects with a history of H. pylori eradication therapy, a significant clinical illness (e.g. malignancy)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsushige Sugimoto
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2261
Email mitsu@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shu Sahara
Organization Hamamatsu University School of Medicine
Division name First Department of Medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2261
Homepage URL
Email ss812765@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Japanese Association of Dialysis Physicians
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 15 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 Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 02 Month 16 Day
Date analysis concluded
2016 Year 02 Month 16 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 21 Day
Last modified on
2016 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017335

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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