UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018835 |
|---|---|
| Receipt number | R000021739 |
| Scientific Title | Exploratory clinical trial of the new third line Helicobacter pylori eradication therapy using vonoprazan |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/03/30 14:53:52 |
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Basic information
Public title
Exploratory clinical trial of the new third line Helicobacter pylori eradication therapy using vonoprazan
Acronym
Efficacy of the new third line Helicobacter pylori eradication therapy using vonoprazan
Scientific Title
Exploratory clinical trial of the new third line Helicobacter pylori eradication therapy using vonoprazan
Scientific Title:Acronym
Efficacy of the new third line Helicobacter pylori eradication therapy using vonoprazan
Region
| Japan |
Condition
Condition
Helicobacter infection with previous eradication failure
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the new third line therapy using vonoprazan
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of Helicobacter pylori 8-12 wks after treatment
Key secondary outcomes
Rate of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Sitafloxacin 100mg bid
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 with two eradication failures by clarithromycin and metronidazole based regimen
Key exclusion criteria
Pregnancy
Lactation
Allergy for the study drugs
Severe major organ dysfunction
Patients who are judged by the investigators to be inappropriate for this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3815-5411
hiratay-int@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-3815-5411
Homepage URL
yamada-a@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, The University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021739
