UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers
Title of the study (Brief title)	Effect of Vonoprazan on Healing Rate of Peptic Ulcers
Region	Japan

Condition
Condition	Peptic Ulcers
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of a New Potent Acid Inhibitory Drug, Vonoprazan on Healing Rate of Peptic Ulcers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to check the healing status of the peptic ulcers (gastric ulcer, 8 weeks after / duodenal ulcer, 6 weeks after)
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	the patients with peptic ulcers confirmed endoscopically
Key exclusion criteria	inpatient with another disease a patient with the disease which has the risk of peptic ulcer a patient who underwent GI tract operation before malignant ulcer ulcers located at duodenal 2nd portion a patient who were administrated vonoprazan 20mg before
Target sample size	300

Research contact person
Name of lead principal investigator	Shigeto Koizumi
Organization	Akita University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-1-1, Hondo, Akita City, Akita, Japan
TEL	018-884-6104
Email	shigeto@doc.med.akita-u.ac.jp

Public contact
Name of contact person	Shigeto Koizumi
Organization	Akita University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-1-1, Hondo, Akita City, Akita, Japan
TEL	018-884-6104
Homepage URL
Email	shigeto@doc.med.akita-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Akita University Graduate School of Medicine
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)

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	2017 Year 12 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	study design: multicenter prospective observational study to investigate the cause of the peptic ulcers before therapy, and to check the healing status of the peptic ulcers after administration of vonoprazan 20mg (gastric ulcer, 8 weeks after / duodenal ulcer, 6 weeks after)

Management information
Registered date	2017 Year 12 Month 13 Day
Last modified on	2017 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034690