UMIN-CTR Clinical Trial

Basic information
Public title	Examination study of the gastroesophageal reflux disease improvement effect by Vonoprazan to the patients with systemic sclerosis
Acronym	Effect of Vonoprazan to gastroesophageal reflux disease with systemic sclerosis
Scientific Title	Examination study of the gastroesophageal reflux disease improvement effect by Vonoprazan to the patients with systemic sclerosis
Scientific Title:Acronym	Effect of Vonoprazan to gastroesophageal reflux disease with systemic sclerosis
Region	Japan

Condition
Condition	Gastroesophageal reflux disease
Classification by specialty	Gastroenterology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of Vonoprazan which is proton pump inhibitor, to patients who suffered from gastroesophageal reflux disease with Systemic sclerosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Levels of IL-8 from tissue of esophageal mucosa taken by biopsy
Key secondary outcomes	Symptoms use of F-scale, pH-monitoring, Grade of reflux disease according to Los-Angeles classification, Esophageal manometry, Background, Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration 20mg of Vonoprazanone for one year
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	1. Over 20 years old, and less than 90 years old. 2. Both of male and female 3. It doesn't no matter with hospitalization or outpatient. 4. Diagnosed accompanied with reflux disease of the newcomer patient, and uncontrolled patient by existing proton pump inhibitor. 5. The patient who have understanding of this study, and obtained written consent by own will.
Key exclusion criteria	1. Liver and kidney dysfunction 2. Allergy to many kind of drugs. 3. Pregnant or who have a possibility to pregnancy, and under nursing patient. 4. Participation to other study in 4 months. 5. The study patient who decided to inadequacy by person in charge. 6. Administration of atazanavir sulfate and rilpivirin hydrochloryde. 7. Severe allergy or complication history of vonoprazan.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Nakao
Organization	Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Science, Nagasaki University Hospital, Nagasaki, Japan
Division name	Department of Gastroenterology and Hepatology
Zip code	852-8501
Address	Nagasaki University Graduate School of Biomedical Science 1-7-1 Sakamoto, Nagasaki city, Japan, 852-8501
TEL	095-819-7481
Email	kazuhiko@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Tabuchi
Organization	Nagasaki University Hospital
Division name	Department of Gastroenterology
Zip code	852-8501
Address	Nagasaki University Graduate School of Biomedical Science 1-7-1 Sakamoto, Nagasaki city, Japan, 852
TEL	095-819-7481
Homepage URL
Email	rururu_rarara_my_b_f_ar@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Clinical Research Center, Nagasaki university hospital
Address	Nagasaki University Graduate School of Biomedical Science 1-7-1 Sakamoto, Nagasaki city, Japan, 852-8501
Tel	095-819-7726
Email	rinshou7726@umin.ac.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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 08 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
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	Main results already published
Date of protocol fixation	2016 Year 06 Month 28 Day
Date of IRB	2016 Year 06 Month 28 Day
Anticipated trial start date	2016 Year 06 Month 28 Day
Last follow-up date	2018 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 30 Day
Last modified on	2021 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027874