UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016601 |
|---|---|
| Receipt number | R000019265 |
| Scientific Title | A randomized controlled study to examine the effects of a triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients. |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2018/08/06 23:35:56 |
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Basic information
Public title
A randomized controlled study to examine the effects of a triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients.
Acronym
A triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients
Scientific Title
A randomized controlled study to examine the effects of a triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients.
Scientific Title:Acronym
A triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between a triple therapy with vonoprazan and a triple therapy with rabeprazole against standard triple therapy-failed patients, and investigation of their adverse effects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison on an eradication rate between a triple therapy with vonoprazan and a triple therapy with rabeprazole
Key secondary outcomes
Comparison of adverse effects between a triple therapy with vonoprazan and a triple therapy with rabeprazole
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan, metronidazole, amoxicillin
Interventions/Control_2
rabeprazole, metronidazole, amoxicillin
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who failed standard triple therapy
Key exclusion criteria
1. Patients who cannot cancel a proton pump inhibitor for 2 weeks before judgment after re-eradication therapy.
2. Patients who have past history of drug allergy.
3. Patients who have severe diseases affecting the kidney, the heart, and the liver.
4. Patients who are pregnant, who may be pregnant, or who are nursing.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
mhojo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
mhojo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Gstroenterology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Department of Gstroenterology
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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 26 | 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 | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019265
