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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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