UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032109
Receipt number R000036631
Scientific Title Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial
Date of disclosure of the study information 2018/04/06
Last modified on 2020/02/06 13:30:34

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Basic information

Public title

Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial

Acronym

RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients

Scientific Title

Sequential therapy with vonoprazan, amoxicillin 7 days and vonoprazan, metronidazole, and sitafloxacin 7 days versus triple therapy with vonoprazan, amoxicillin, and metronidazole 7days for early age Helicobacter pylori infection: a multicentre, open-label, randomised trial

Scientific Title:Acronym

RCT comparing VA-VMS sequential and VAM HP eradication for Early age patients

Region

Japan


Condition

Condition

Helicobacter pylori infection

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety between sequential therapy with vonoprazan-amoxicillin and vonoprazan-metronidazole-sitafloxacin and triple therapy with vonoprazan-amoxicillin-metronidazole as the first-line treatment for Helicobacter pylori positive patients less than 40 year-old.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Eradication rate assessed by stool antigen test of Helicobacter pylori more than 8 weeks after treatment

Key secondary outcomes

Adverse event evaluated by side effect questionnaire filled by patients


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

A 14-day sequential therapy conaining vonoprazan and amoxicillin for 7 days followed by vonoprazan, metronidazole and sitafloxacin for 7 days
: Vonoprazan 20mg bid
Amoxicillin 750mg bid
7 days
followed by
Vonoprazan 20mg bid
Metronidazole 250mg bid
Sitafloxacin 100mg bid
7 days
(Total 14 days)

Interventions/Control_2

A 7-day triple therapy with vonoprazan, amoxicillin, and metronidazole
:Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
7 days

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

40 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) A patient with Helicobacter pylori infection.
(2) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion.
(3)A patient who give a written informed consent.

Key exclusion criteria

(1) A patient with history of Helicobacter pylori eradication.
(2) Pregnancy.
(3) Lactation.
(4) Patients allergic to penicillin.
(5) Past history of allergy for the drugs used in this study.
(6) A patient with brain and spinal cord disease.
(7) A patient with infectious mononucleosis.
(8) Severe liver dysfunction, serere renal dysfunction, severe heart dysfunction.
(9) Patient who is disualified for the study by physicians.

Target sample size

190


Research contact person

Name of lead principal investigator

1st name Shin
Middle name
Last name Maeda

Organization

Yokohama City University Hospital

Division name

Gastroenterology

Zip code

236-0004

Address

Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan

TEL

045-787-2326

Email

smaeda@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Soichiro
Middle name
Last name Sue

Organization

Yokohama City University Hospital

Division name

Gastroenterology

Zip code

236-0004

Address

Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan

TEL

045-787-2326

Homepage URL


Email

ssue@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University (Basic research expenditures)

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

Yokohama City University Certified Institutional Review Board

Address

Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa

Tel

045-370-7627

Email

ycu_crb@yokohama-cu.ac.jp


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

2018 Year 04 Month 06 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

2018 Year 03 Month 22 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 01 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

2018 Year 04 Month 04 Day

Last modified on

2020 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name