UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018654 |
|---|---|
| Receipt number | R000021592 |
| Scientific Title | Randomized comparative trial of vonoprazan and esomeprazole in triple therapy for the eradication of Helicobacter pylori. |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2021/10/15 10:59:45 |
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Basic information
Public title
Randomized comparative trial of vonoprazan and esomeprazole in triple therapy for the eradication of Helicobacter pylori.
Acronym
Comparative trial of vonoprazan and esomeprazole for the eradication of Helicobacter pylori (VEHP trial)
Scientific Title
Randomized comparative trial of vonoprazan and esomeprazole in triple therapy for the eradication of Helicobacter pylori.
Scientific Title:Acronym
Comparative trial of vonoprazan and esomeprazole for the eradication of Helicobacter pylori (VEHP trial)
Region
| Japan |
Condition
Condition
Chronic gastritis with Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of vonoprazan based triple therapy compared with esomeprazole based therapy as first-line eradication therapy for patients with Helicobacter pylori infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Eradication rate of the first-line therapy assessed by a urea breath test from 6 to 10 weeks after cessation of therapy.
Key secondary outcomes
Eradication rate of second-line therapy with vonoprazan in the patients who failed first-line therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 40mg, ABPC 1500mg, CAM 400mg, for the first 7days, with all drugs given twice daily
Interventions/Control_2
Esomeprazole 40mg, ABPC 1500mg, CAM 400mg, for the first 7 days, with all drugs given twice daily
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 received a diagnosis of Helicobacter pylori gastritis by any one method of a rapid urease test, a urea breath test, a blood antibody test, a stool antigen test, and microbial culture.
Key exclusion criteria
1. Patients who suggested or received a diagnosis of other infectious diseases.
2. Patients who received a diagnosis of acute gastritis, advanced gastric cancer, gastric MALT lymphoma, and postgastrectomy by endoscopic examination.
3. Patients who have coexisting severe heart disease, liver disease, renal disease, respiratory disease, metabolic disease, and neuromuscular disease.
4. Patients who received any one of lansoprazole, esomeprazole, omeprazole, and vonoprazan within 2 weeks.
5. Patients who have histories of eradication therapy for Helicobacter pylori.
6. Patients who have a past history of allergy for vonoprazan, esomeprazole, amoxicillin, clarithromycin, and metronidazor.
7. Pregnancy.
Target sample size
520
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tamaki |
Organization
Takamatsu Redcross Hospital
Division name
Gastroenterology
Zip code
7600075
Address
4-1-3, Ban-cho, Takamatsu , Kagawa
TEL
087-831-7101
h-tama@gc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tamaki |
Organization
Takamatsu Redcross Hospital
Division name
Gastroenterology
Zip code
7600075
Address
4-1-3, Ban-cho, Takamatsu , Kagawa
TEL
087-831-7101
Homepage URL
h-tama@gc4.so-net.ne.jp
Sponsor or person
Institute
Takamatsu Redcross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Takamatsu Red Cross Hospital
Address
4-1-3, Ban-cho, Takamatsu, Kagawa, Japan
Tel
0878317101
tamaki33@gmail.com
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
高松赤十字病院（香川）、石川クリニック（香川）、関西電力病院（大阪）、なお消化器クリニック（静岡）、天理よろづ相談所病院（奈良）、よしなれクリニック（香川）、なかじまクリニック（兵庫）、京都桂病院（京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 08 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021592
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| Registered date | File name |
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| Registered date | File name |
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