UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024236
Receipt No. R000027874
Scientific Title Examination study of the gastroesophageal reflux disease improvement effect by Vonoprazan to the patients with systemic sclerosis
Date of disclosure of the study information 2016/10/08
Last modified on 2017/07/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kazuhiko 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
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
Middle name
Last name Maiko Tabuchi
Organization Nagasaki University Hospital
Division name Department of Gastroenterology
Zip code
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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 28 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
2016 Year 09 Month 30 Day
Last modified on
2017 Year 07 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.