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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022006
Receipt No. R000025345
Scientific Title Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection
Date of disclosure of the study information 2016/04/22
Last modified on 2016/05/05

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Basic information
Public title Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection
Acronym Comparison of vonoprazan and lansoprazole
Scientific Title Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection
Scientific Title:Acronym Comparison of vonoprazan and lansoprazole
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the healing effect of P-CAB (vonoprazan) and PPI (lansoprazole) on ESD-induced ulcers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint was to evaluate the shrinking rate of ESD-induced ulcers between vonoprazan (20mg/day) group and lansoprazole (30mg/day) group 28 days after ESD.
Key secondary outcomes The secondary endpoint was to compare the preventive effect of vonoprazan and lansoprazole for delayed bleeding

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients were prospectively and randomly assigned into either vonoprazan group or lansoprazole group. The day before ESD, patients were admitted. After the ESD,patients in vonoprazan group began to take vonoprazan 20mg daily until the protocol finished. Eight days and 28 days after ESD, patients underwent follow-up EGD and the shrinking rate of the ulcers on day 8th and 28th was evaluated between the 2 groups.
Interventions/Control_2 Patinets in lansoprazole group began to took lansoprazole 30mg daily until the protocol finished.
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 Thirty consecutive patients, who underwent ESD for early gastric cancer between August 2015 and March 2016 at Sado General Hospital, were enrolled in this study. Patients who had undergone gastric surgery before ESD were not included in this study.
Key exclusion criteria Those who needed any additional anticancer therapy (surgery and/or chemotherapy) after ESD were excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Takahashi
Organization Niigata University Medical and Dental Hospital, Niigata, Japan
Division name Division of Gastroenterology and Hepatology
Zip code
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-223-2207
Email kazuya911@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Takahashi
Organization Niigata University Medical and Dental Hospital, Niigata, Japan
Division name Division of Gastroenterology and Hepatology
Zip code
Address 757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL 025-223-2207
Homepage URL
Email kazuya911@hotmail.co.jp

Sponsor
Institute Sado general hospital
Institute
Department

Funding Source
Organization not applicable
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

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 22 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
Our study indicated that lansoprazole was cost-effective and potent enough for the management of ESD ulcers, although vonoprazan is also sufficient.
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
2015 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 19 Day
Last follow-up date
2016 Year 04 Month 07 Day
Date of closure to data entry
2016 Year 05 Month 05 Day
Date trial data considered complete
2016 Year 05 Month 05 Day
Date analysis concluded
2016 Year 05 Month 05 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2016 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025345

Research Plan
Registered date File name
2016/05/05 タケキャブ研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/05/05 アップロード.xlsx


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