UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016642
Receipt No. R000019318
Scientific Title Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Date of disclosure of the study information 2015/02/27
Last modified on 2020/07/21 (Ver. 7)

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Basic information
Public title Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Acronym Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Scientific Title Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Scientific Title:Acronym Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Region
Japan

Condition
Condition gastric neoplasm
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to evaluate the effectiveness of Vonoprazan in patients with post-ESD gastric ulcer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement of post-operative gastric ulcer
Key secondary outcomes Rate of post-operative bleeding

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.
Interventions/Control_2 We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.
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 with gastric tumors whom concents has been obtained to participate in this study, which has been approved by the ethics committee

Key exclusion criteria Remnant stomach, administration of antithrombotic agents, non-steroidal anti-inflammatory drugs and steroids, occurrence of complication during ESD, allergy to lansoprazole or vonoprazan, and unwillingness to participate in the study.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Takenaka
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code 708-0841
Address 1756 Kawasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Email daicawai@yahoo.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Kawai
Organization Tsuyama Chuo Hospital
Division name Department of Gastroenterology
Zip code 708-0841
Address 1756 Kwasaki-Tsuyama-city, Okayama
TEL 0868-21-8111
Homepage URL
Email daicawai@yahoo.co.jp

Sponsor
Institute Tsuyama Chuo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsuyama Chuo Hospital
Address 1756, Kawasaki, Tsuyama City
Tel 0878-21-8111
Email daicawai@yahoo.co.jp

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
2015 Year 02 Month 27 Day

Related information
URL releasing protocol A prospective, randomized controlled trial of vonoprazan versus lansoprazole
Publication of results Partially published

Result
URL related to results and publications Vonoprazan is not superior to lansoprazole in the healing of artificial gastric ulcer after ESD.
Number of participants that the trial has enrolled 168
Results 
A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in Vonoprazan group versus group Lansoprazole (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups.
Results date posted
2020 Year 06 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
A total of 168 patients were analyzed.
Participant flow 
Patients with gastric tumors were randomly 
assigned to the vonoprazan group or lansoprazole group after ESD.
Adverse events 
Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD.
Outcome measures 
The 4-week healing rate for artificial ulcer
and the 4-week shrinkage rates
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 25 Day
Date of IRB
2015 Year 02 Month 01 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 26 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019318