UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021521 |
|---|---|
| Receipt number | R000024708 |
| Scientific Title | Efficacy of Vonoprazan for sleeping dysorder caused by gastroesophageal reflux disease (GERD) symptoms. |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2017/03/20 12:25:22 |
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Basic information
Public title
Efficacy of Vonoprazan for sleeping dysorder caused by gastroesophageal reflux disease (GERD) symptoms.
Acronym
Efficacy of Vonoprazan for sleeping dysorder caused by GERD symptoms.
Scientific Title
Efficacy of Vonoprazan for sleeping dysorder caused by gastroesophageal reflux disease (GERD) symptoms.
Scientific Title:Acronym
Efficacy of Vonoprazan for sleeping dysorder caused by GERD symptoms.
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease (GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An investigation of the efficacy of Vonoprazan for sleeping dysorder caused by GERD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
An improvement of the sleeping dysorder caused by GERD, in 4, 8, 12 and 16 weeks after start of administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Vonoprazan 20mg/day for 8 weeks p.o., continued by 10mg/day for 8 weeks p.o.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An outpatient who is diagnosed as reflux esophagitis LA grade A-D by EGD, and who has spleeping dysorder caused by GERD.
No history of recent administration of PPI for 8 weeks.
Key exclusion criteria
Having oral medicine which may effect gastrointestinal motility.
Equivalent to contraindications of the package insert of Vonaprazan.
No history of upper gastrointestinal operation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahi-machi, Machida, Tokyo, Japan
TEL
042-722-2230
m.izumi@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahi-machi, Machida, Tokyo, Japan
TEL
042-722-2230
Homepage URL
m.izumi@machida-city-hp.jp
Sponsor or person
Institute
Machida municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Machida municipal hospital
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
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
| 2016 | Year | 03 | Month | 18 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024708
