UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021383 |
|---|---|
| Receipt number | R000024481 |
| Scientific Title | Investigation of improved Helicobacter pylori eradication rate using Vonoprazan for first-line therapy: large prospective study. |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2019/02/20 12:53:49 |
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Basic information
Public title
Investigation of improved Helicobacter pylori eradication rate using Vonoprazan for first-line therapy: large prospective study.
Acronym
H. pylori eradication rate using Vonoprazan
Scientific Title
Investigation of improved Helicobacter pylori eradication rate using Vonoprazan for first-line therapy: large prospective study.
Scientific Title:Acronym
H. pylori eradication rate using Vonoprazan
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the Helicobacter pylori eradication of first-line therapy using Vonoprazan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of Helicobacter pylori
Key secondary outcomes
Changes of abdominal symptom (GSRS)
Risk factors for the failure of Helicobacter pylori eradication
(Age, Sex, smoking habit, drinking habit, obesity, past history, medication)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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 / Vonoprazan 20mg bid
Amoxicillin 750mg / Amoxicillin 750mg bid
Clarithromycin 400mg / Clarithromycin 400mg bid
daily for 7 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Helicobacter pylori infection
Willingness to provide informed consent.
Key exclusion criteria
Patients with gastric cancer identified by initial gastroduodenal endoscopy
Patients who hava allergy to eraducation drugs
Patients who have severe diseases
affecting the kidney.
Patients who have severe diseases affecting the heart.
Patients who have severe diseases affecting the liver.
Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Misumi |
Organization
NTT Medical Center Tokyo
Division name
Gastroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo,141-8625,Japan
TEL
03-3448-6547
yoshikft34@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Misumi |
Organization
NTT Medical Center Tokyo
Division name
Gastroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo,141-8625,Japan
TEL
03-3448-6547
Homepage URL
yoshikft34@gmai.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
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
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
| 2016 | Year | 03 | Month | 07 | 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
| 2016 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2019 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024481
