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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018595
Receipt No. 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

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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
Email 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
Email chiaki_kusumoto@nkfh.or.jp

Sponsor
Institute Nippon Kokan Fukuyama Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021513

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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