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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021010
Receipt No. R000024216
Scientific Title Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Date of disclosure of the study information 2016/02/14
Last modified on 2016/07/23

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Basic information
Public title Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Acronym Effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer
Scientific Title Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Scientific Title:Acronym Effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer
Region
Japan

Condition
Condition Post-ESD(endoscopic submucosal dissection) artificial gastric ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to assess the effect of treatment for post-ESD ulcers by Vonoprazan at 5weeks at cost equivalent to proton pomp inhibitor(PPI) at 8weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes We assessed the rate of decrease in ulcer size and the postoperative bleeding rate
Key secondary outcomes

Base
Study type Observational

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

Not applicable
Gender Male and Female
Key inclusion criteria The study subjects were 75 consecutive patients who treated by Vonoplazan (20mg /day, 5week) after endoscopic submucosal dissection(ESD) for early gastric neoplasm from April 2014 to February 2015 at our hospital.

Control subjects were selected from among 870 patients who had treated by PPI(Rabeprazole 20mg/day, 8week) for artificial gastric ulcer after endoscopic submucosal dissection(ESD) from April 2005 to March 2014 at our hospital.
Age-, sex-, the size of ulcer- and Helicobacter pylori infection-matched two control subjects were selected for one case subject(control group).
Key exclusion criteria Patients who received additional chemotherapy or surgical treatment after endoscopic submucosal dissection(ESD)

Patients who discontinued Vonoprazan due to side effects

Remnant stomach
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigenao Ishikawa
Organization Kagawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL 087-811-3333
Email ishikawa5308@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigenao Ishikawa
Organization Kagawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL 087-811-3333
Homepage URL
Email ishikawa5308@yahoo.co.jp

Sponsor
Institute Kagawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization none
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 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 02 Month 28 Day

Other
Other related information The aim of this study was to assess the effect of the Vonoprazan and the PPI for the ulcer healing and the prevention of bleeding after ESD.
The study subjects were consecutive patients who underwent ESD for superficial gastric neoplasm. Comparison objects were 150 patients who were treated by PPI for post-ESD ulcers.We assessed the rate of decrease in ulcer size and the postoperative bleeding rate in the two groups.
This study was case-control study.

Management information
Registered date
2016 Year 02 Month 13 Day
Last modified on
2016 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024216

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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