UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized controlled trial of clarithromycin 800 mg versus 400 mg as part of first-line triple therapy with vonoprazan for Helicobacter pylori gastritis
Acronym	A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Scientific Title	A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Scientific Title:Acronym	A RANDOMIZED TRIAL OF CLARITHROMYCIN 800 mg VERSUS 400 mg AS PART OF FIRST-LINE TRIPLE THERAPY
Region	Japan

Condition
Condition	Helicobacter pylori gastritis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the eradication rate of clarithromycin doses of 400 mg and 800 mg in the first-line triple therapy using vonoprazan for Helicobacter pylori gastritis.
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 8 to 12 weeks after cessation of therapy.
Key secondary outcomes	Effects of clarithromycin resistance, eGFR, alcohol consumption, and smoking on the eradication rate of each group, and the incidence and severity of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan (VPZ) 20mg, Amoxicillin (ABPC) 750mg, Clarithromycin (CAM) 200mg, for the first 7days, with all drugs given twice daily
Interventions/Control_2	VPZ 20mg, ABPC 750mg, CAM 400mg, for the first 7days, 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 have histories of eradication therapy for Helicobacter pylori. 2. Patients who received any one of lansoprazole, esomeprazole, omeprazole, and vonoprazan within 2 weeks. 3. Patients who suggested or received a diagnosis of other infectious diseases. 4. Patients being treated for acute gastritis, advanced gastric cancer, and gastric MALT lymphoma. 5. Patients after gastrectomy. 6. Patients who have coexisting severe heart disease, liver disease, respiratory disease, metabolic disease, neuromuscular disease, and severe chronic renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2). 7. Patients who have a past history of allergy for vonoprazan, esomeprazole, amoxicillin, and clarithromycin. 8. Pregnancy or lactating women. 9. Patients requiring hospitalization..
Target sample size	516

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Tamaki
Organization	Takamatsu Red Cross Hospital
Division name	Department of gastroenterology
Zip code	7600017
Address	4-1-3, Ban-cho, Takamatsu , Kagawa, Japan
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 Red Cross Hospital
Division name	Department of gastroenterology
Zip code	7600017
Address	4-1-3, Ban-cho, Takamatsu , Kagawa, Japan
TEL	0878317101
Homepage URL
Email	h-tama@gc4.so-net.ne.jp

Sponsor
Institute	Takamatsu Red Cross 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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 21 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	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 10 Day
Date of IRB	2017 Year 04 Month 18 Day
Anticipated trial start date	2017 Year 05 Month 13 Day
Last follow-up date	2022 Year 05 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 19 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048851