UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014910 |
|---|---|
| Receipt number | 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 16:44:05 |
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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
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
ss812765@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017335
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
