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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022891
Receipt No. R000026381
Scientific Title A Comparative Study of Potassium-Competitive Acid Blocker (Vonoprazan) and Proton Pomp Inhibitors in Helicobacter Pylori Eradication Therapy.
Date of disclosure of the study information 2016/07/15
Last modified on 2016/06/26

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Basic information
Public title A Comparative Study of Potassium-Competitive Acid Blocker (Vonoprazan) and Proton Pomp Inhibitors in Helicobacter Pylori Eradication Therapy.
Acronym H. pylori eradication therapy
Scientific Title A Comparative Study of Potassium-Competitive Acid Blocker (Vonoprazan) and Proton Pomp Inhibitors in Helicobacter Pylori Eradication Therapy.
Scientific Title:Acronym 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.

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

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
1st name
Middle name
Last name Kouichi Sakurai
Organization Hattori Clinic
Division name Hattori Clinic
Zip code
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
1st name
Middle name
Last name Kouichi Sakurai
Organization Hattori Clinic
Division name Hattori Clinic
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
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

Other
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

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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