UMIN-CTR Clinical Trial

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