UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018595 |
|---|---|
| Receipt number | R000021513 |
| Scientific Title | A trial to study of treatment with a new PPI for infection of H. pylori with Clarithromycin resistance |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2017/02/09 11:16:12 |
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Basic information
Public title
A trial to study of treatment with a new PPI for infection of H. pylori with Clarithromycin resistance
Acronym
A trial to study of treatment with a new PPI for infection of H. pylori with Clarithromycin resistance
Scientific Title
A trial to study of treatment with a new PPI for infection of H. pylori with Clarithromycin resistance
Scientific Title:Acronym
A trial to study of treatment with a new PPI for infection of H. pylori with Clarithromycin resistance
Region
| Japan |
Condition
Condition
Chronic gastritis infected by H. pylori with Clarithromycin resistance
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A trial to study of treatment with "vonoprazan" for infection of H. pylori with Clarithromycin resistance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate
Urease Breath Test(UBT) will be performed at six to twelve weeks after HP eradication.
Key secondary outcomes
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rabeprazole 10mg, Amoxicillin 750mg and Metronidazole 250mg
bid(bis in die), for 1 week.
Interventions/Control_2
Vonoprazan 20mg, Amoxicillin 750mg and Metronidazole 250mg
bid(bis in die), for 1 week.
Interventions/Control_3
Vonoprazan 20mg, Amoxicillin 750mg and Clarithromycin 200/400mg
bid(bis in die), for 1 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of chronic gastritis infected by H. pylori with Clarithromycin resistance, who want to eradicate HP.
Key exclusion criteria
Patients who could not agree with this trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiaki KUSUMOTO |
Organization
Nippon Kokan Fukuyama Hospital
Division name
Dep. of Gastroenterology
Zip code
Address
1844 Tsunoshita, Daimon, Fukuyama, 721-0927, JAPAN
TEL
084-945-3106
chiaki_kusumoto@nkfh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki KUSUMOTO |
Organization
Nippon Kokan Fukuyama Hospital
Division name
Dep. of Gastroenterology
Zip code
Address
1844 Tsunoshita, Daimon, Fukuyama, 721-0927, JAPAN
TEL
084-945-3106
Homepage URL
chiaki_kusumoto@nkfh.or.jp
Sponsor or person
Institute
Nippon Kokan Fukuyama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
日本鋼管福山病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | 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
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021513
