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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018654
Receipt No. 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

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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
Email 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
Email h-tama@gc4.so-net.ne.jp

Sponsor
Institute Takamatsu Redcross Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021592

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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