UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparative Study of Potassium-Competitive Acid Blocker (Vonoprazan) and Proton Pomp Inhibitors in Helicobacter Pylori Eradication Therapy.
Title of the study (Brief title)	H. pylori eradication therapy
Region	Japan

Condition
Condition	H. pylori-positive patients diagnosed with gastric/duodenal ulcer history, MALT lymphoma, post endoscopic submucosal dissection for early gastric cancer and atrophic gastritis by upper gastrointestinal endoscopy using a high-resolution endoscope
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we evaluated the clinical effectiveness and safety of Vonoprazan-based H. pylori eradication therapy compared to conventional PPI-based therapy in clinical practice from April 2014 to December 2015 at Hattori clinic.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint was eradication rate from April 2014 to December 2015 at Hattori clinic.
Key secondary outcomes	The secondary endpoint was evaluation of adverse events.Adverse events were defined as undesirable medical symptoms or conditions, which Patients were interviewed at the timing of eradication determination.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	H. pylori-positive patients diagnosed with gastric/duodenal ulcer history, MALT lymphoma, post endoscopic submucosal dissection for early gastric cancer and atrophic gastritis by upper gastrointestinal endoscopy using a high-resolution endoscope (GIF260, 290 series; Olympus, Tokyo, Japan) from April 2014 to December 2015 at Hattori clinic were enrolled in this study.
Key exclusion criteria	Exclusion criteria were as follows: age less than 20 years, past history of total gastrectomy, history of drug allergy to PPIs, AMPC, CAM or MNZ, clinically significant disease (hepatic, renal or cardiac disease) and pregnancy.
Target sample size	1353

Research contact person
Name of lead principal investigator	Kouichi Sakurai
Organization	Hattori Clinic
Division name	Hattori Clinic
Address	2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL	+81-96-325-2300
Email	sakurai@s3.kcn-tv.ne.jp

Public contact
Name of contact person	Kouichi Sakurai
Organization	Hattori Clinic
Division name	Hattori Clinic
Address	2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL	+81-96-325-2300
Homepage URL
Email	sakurai@s3.kcn-tv.ne.jp

Sponsor
Institute	Hattori Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hattori Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	服部胃腸科

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 06 Month 05 Day
Date analysis concluded	2016 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We retrospectively examined our data on the patients administered first-line and/or second-line eradication therapy.The primary endpoint was eradication rate. The secondary endpoint was evaluation of adverse events. Subgroup analyses of demographic and clinical characteristics including endoscopic gastric atrophy, age, gender, alcohol consumption, body mass index (BMI) and smoking were also conducted.

Management information
Registered date	2016 Year 06 Month 26 Day
Last modified on	2016 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026381