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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034749
Receipt No. R000039545
Official scientific title of the study Telemedicine vs hospital based medicine for assessment of Helicobacter pylori eradication: randomised controlled trial
Date of disclosure of the study information 2018/11/06
Last modified on 2018/11/02

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Basic information
Official scientific title of the study Telemedicine vs hospital based medicine for assessment of Helicobacter pylori eradication: randomised controlled trial
Title of the study (Brief title) RCT of Telemedicine for assessment of Helicobacter pylori eradication
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the telemedicine and hospital based medicine in the assessment of Helicobacter pylori eradication therapy success about the following points:
(1) Reliability and compliance of the Urea Breath Test
(2) Questionnaire based evaluation by patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eradication rate (ITT analysis) and assessment of burden by questionnaire
Key secondary outcomes Eradication rate (PP analysis)

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Telemedicine:Urea breath test at home by patient and breath bag is sent by post for the assessment of Helicobacter pylori eradication success and result description by the telemedicine system
Interventions/Control_2 Hospital based medicine:Assessment of Helicobacter pylori eradication success by urea breath test and result description at the hospital
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
65 years-old >=
Gender Male and Female
Key inclusion criteria (1)A patient with Helicobacter pylori infection without history of eradication therapy
(2)A patient who is willing to eradicate the Helicobacter pylori with triple therapy (containing amoxicillin + clarithromycin or metronidazole)
(3)A patient who understand the risk of telemedicine system, agreed the terms of use and expected to participate
(4)A patient who agreed not to storage or leak the video and voice of telemedicine
(5)A patient who give a written informed consent
Key exclusion criteria (1)Patients allergic to penicillin
(2)Pregnancy
(3)Lactation
(4)A patient with brain and spinal cord disease
(5)A patient with infectious mononucleosis
(6)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction
Target sample size 172

Research contact person
Name of lead principal investigator Soichiro Sue
Organization Yokohama City University Hospital
Division name Gastroenterology
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-787-2326
Email ssue@yokohama-cu.ac.jp

Public contact
Name of contact person Soichiro Sue
Organization Yokohama City University Hospital
Division name Gastroenterology
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-787-2326
Homepage URL
Email ssue@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Takeda Japan Medical Affairs Funded Research Grant
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 11 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 09 Day
Anticipated trial start date
2018 Year 11 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039545

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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