UMIN-CTR Clinical Trial

Basic information
Public title	Telemedicine vs hospital based medicine for assessment of Helicobacter pylori eradication: randomised controlled trial
Acronym	RCT of Telemedicine for assessment of Helicobacter pylori eradication
Scientific Title	Telemedicine vs hospital based medicine for assessment of Helicobacter pylori eradication: randomised controlled trial
Scientific Title:Acronym	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	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
Email	ssue@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
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)

IRB Contact (For public release)
Organization	Yokohama City University Ethics Committee
Address	Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel	045-370-7627
Email	rinri@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 11 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 07 Month 09 Day
Date of IRB	2018 Year 07 Month 17 Day
Anticipated trial start date	2018 Year 11 Month 06 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 02 Day
Last modified on	2020 Year 02 Month 06 Day

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