UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022891 |
|---|---|
| Receipt number | 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 20:54:24 |
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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
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
sakurai@s3.kcn-tv.ne.jp
Sponsor or person
Institute
Hattori Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026381
