UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030270
Receipt number R000026664
Scientific Title Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents
Date of disclosure of the study information 2017/12/05
Last modified on 2017/12/05 15:05:13

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Basic information

Public title

Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents

Acronym

Efficacy of tailored HP eradication based on susceptibility to antimicrobial agents

Scientific Title

Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents

Scientific Title:Acronym

Efficacy of tailored HP eradication based on susceptibility to antimicrobial agents

Region

Japan


Condition

Condition

H. pylori-associated gastritis

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify efficacy of tailored eradication therapy based on susceptibility to antimicrobial agents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Eradication rate of tailored eradication therapy based on susceptibility to antimicrobial agents.

Key secondary outcomes

1. Eradication rate of tailored tailored H. pylori eradication therapy based on susceptibility to antimicrobial agents among different CYP2C19, CYP3A4, CYP3A5 genotypes.
2.Change of abdominal symptoms between before and after eradication therapy


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

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Conventional:7 days
VPZ20mg/AMPC750mg/CAM200mg bid

Interventions/Control_2

Tailored: 7 days
1. CAM-S: VPZ20mg/AMPC750mg/CAM200mg bid
2. CAM-R: VPZ20mg/AMPC750mg/MNZ250mg bid

Interventions/Control_3


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Age; mere than 20 years
2. With informed consent
3. Positive for culture test of H. pylori

Key exclusion criteria

1. With malignant diseases
2. Negative for culture test
3. With severe liver disease
4. No informed consent
5. Not suitable by judgement of Medical Doctor

Target sample size

310


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsushige Sugimoto

Organization

Shiga University of Medical Science Hospital

Division name

Division of Digestive Endoscopy

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2618

Email

sugimo@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsushige Sugimoto

Organization

Shiga University of Medical Science Hospital

Division name

Division of Digestive Endoscopy

Zip code


Address

Seta Tsukinowa-cho, Otsu, Shiga

TEL

077-548-2618

Homepage URL


Email

sugimo@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science Hospital

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science Hospital

Organization

Division

Category of Funding Organization

Other

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

2017 Year 12 Month 05 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

Open public recruiting

Date of protocol fixation

2016 Year 05 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 20 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

2017 Year 12 Month 05 Day

Last modified on

2017 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name