UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022154 |
|---|---|
| Receipt number | R000025525 |
| Scientific Title | Two-dimension tailor-made therapy (2dTMT): a new salvage therapy after multiple eradication failures for Helicobacter pylori infection. |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2022/02/05 06:37:24 |
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Basic information
Public title
Two-dimension tailor-made eradication therapy as the third-line therapy for Helicobacter pylori infection.
Acronym
Two-dimension tailor-made eradication therapy
Scientific Title
Two-dimension tailor-made therapy (2dTMT): a new salvage therapy after multiple eradication failures for Helicobacter pylori infection.
Scientific Title:Acronym
Two-dimension tailor-made eradication therapy
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of the tailor-made eradication therapy for the patients who failed twice or more eradication therapies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eradication success is evaluated 2
months or later after eradication therapy.
Key secondary outcomes
Safety is evaluated with adverse events during the therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A proton pump inhibitor and two antibiotics are prescribed.
Interventions/Control_2
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
Patients who are positive for H. pylori after twice or more eradication therapies.
Key exclusion criteria
Those who do not want to undergo eradication therapy anymore.
Those who discontinued previous eradication therapies because of adverse events.
Those who have severe liver or renal diseases or other conditions which are not adequate to enter the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Shigemi |
| Middle name | |
| Last name | Nakajima |
Organization
Japan Community Health care Organization Shiga Hospital
Division name
Department of General Medicine
Zip code
520-0846
Address
16-1 Fujimidai, Otsu city, Shiga 520-0846, Japan
TEL
077-537-3101
shigemin@rainbow.plala.or.jp
Public contact
Name of contact person
| 1st name | Shigemi |
| Middle name | |
| Last name | Nakajima |
Organization
JCHO Shiga Hospital
Division name
Department of General Medicine
Zip code
520-0846
Address
16-1 Fujimidai, Otsu city, Shiga 520-0846, Japan
TEL
077-537-3101
Homepage URL
shigemin@rainbow.plala.or.jp
Sponsor or person
Institute
Department of General Medicine, JCHO Shiga Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
JCHO Shiga Hospital
Address
16-1 Fujimidai, Otsu, Shiga, Japan
Tel
077-537-3101
chiken@shiga.jcho.go.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
JCHO滋賀病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://shiga.jcho.go.jp/%e3%83%86%e3%83%bc%e3%83%a9%e3%83%bc%e3%83%a1%e3%82%a4% e3%83%89%e9%99%a4%e
Publication of results
Published
Result
URL related to results and publications
https://www.ghadvances.org/article/S2772-5723(21)00032-7/fulltext
Number of participants that the trial has enrolled
51
Results
Eradication rate of 2-dimension tailor-made therapy (2dTMT) was 86.4% (95%CI: 65.1-98.8%) in ITT and 90.5% (95%CI: 69.6-98.8%) in PP analyses.
Eradication rate of 1-dimension tailor-made therapy (1dTMT) was 75.0% (95%CI: 42.8-94.5%) in ITT and 90.0% (95%CI: 55.5-99.7%)in PP analyses.
Results date posted
| 2021 | Year | 08 | Month | 31 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Manuscript is accepted by Gastro Hep Advances.
https://www.ghadvances.org/article/S2772-5723(21)00032-7/fulltext
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 26 | Day |
Baseline Characteristics
See the journal paper.
Participant flow
See the journal paper.
Adverse events
No serious adverse events were reported in either of the groups
Outcome measures
Eradication rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 30 | Day |
Last modified on
| 2022 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025525
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
