UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024236 |
|---|---|
| Receipt number | 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 | 2021/10/07 01:04:38 |
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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
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
rururu_rarara_my_b_f_ar@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027874
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| Registered date | File name |
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