UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034749 |
|---|---|
| Receipt number | R000039545 |
| Scientific Title | 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 | 2020/02/06 13:35:43 |
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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
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
ssue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039545
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| Registered date | File name |
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