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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016601
Receipt No. 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

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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
Email 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
Email mhojo@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Department of Gstroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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