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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019516
Receipt No. R000022573
Scientific Title A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Date of disclosure of the study information 2015/10/27
Last modified on 2018/10/29

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Basic information
Public title A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Acronym A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Scientific Title A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Scientific Title:Acronym A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the healing rate of gastric ulcers induced by endoscopic submucosal dissection(ESD) in response to vonoprazan or esomeprazole administration
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes healing rate and reduction rate of gastric ulcers at 4 and 8 weeks after endoscopic procedure
Key secondary outcomes frequency of post procedure 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 vonoprazan fumarate20mg plus rebamipide300mg/day
Interventions/Control_2 esomeprazole20mg plus rebamipide300mg/day
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 Patients who will undergo ESD for early gastric cancer or adenoma at Tsuchiura kyodo hospital.

Patients with written informed consent.
Key exclusion criteria Patients with the possibility of the pregnancy or the pregnancy
Patients who are lactating
Patients with allergy for the drugs in this trial
Patients with severe liver dysfunction, or heart dysfunction
Patients with perforation during ESD
Patients who are disqualified for this study by physicians
Target sample size 85

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Sakai
Organization Tsuchiura Kyodo General Hospital
Division name Department of gastroenterology
Zip code
Address 11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL 029-823-3111
Email sakai@tkgh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Ichida
Organization Tsuchiura Kyodo General Hospital
Division name Department of gastroenterology
Zip code
Address 11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL 029-823-3111
Homepage URL
Email taka_taka_0621@yahoo.co.jp

Sponsor
Institute Tsuchiura Kyodo General Hospital
Institute
Department

Funding Source
Organization Tsuchiura Kyodo General Hospital
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 土浦協同病院

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 27 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
2015 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 27 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022573

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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