UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018455 |
|---|---|
| Receipt number | R000021376 |
| Scientific Title | Therapeutic Efficacy Ratio and Symptom Improvement Effect of New Potassium Ion-Competitive Acid Blocker (P-CAB) |
| Date of disclosure of the study information | 2015/07/28 |
| Last modified on | 2015/07/29 12:04:34 |
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Basic information
Public title
Therapeutic Efficacy Ratio and Symptom Improvement Effect of
New Potassium Ion-Competitive Acid Blocker (P-CAB)
Acronym
Therapeutic Efficacy Ratio and Symptom Improvement Effect of
New Potassium Ion-Competitive Acid Blocker (P-CAB)
Scientific Title
Therapeutic Efficacy Ratio and Symptom Improvement Effect of
New Potassium Ion-Competitive Acid Blocker (P-CAB)
Scientific Title:Acronym
Therapeutic Efficacy Ratio and Symptom Improvement Effect of
New Potassium Ion-Competitive Acid Blocker (P-CAB)
Region
| Japan |
Condition
Condition
gastroesohageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic Efficacy Ratio
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment reactivity by GerdQ after 20 mg Vonoprazan Fumarate tablets (VFT)administration 4 weeks
Key secondary outcomes
Reflux symptom disapearance by GERDQ and
Frequency Scale for the symptom of GERD (FSSG) and acid reflux related conditions score by FSSG
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are 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
Vonoprazan Fumarate tablets 20 mg/day for 4 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
Eligible, enrolled patients were who had judged to be appropriate to start the treatment of PPIs defined by GerdQ questionnaire and who had judged having insufficient therapeutic effects also defined by GerdQ despite continuing the conventional PPIs for four weeks or more.
Key exclusion criteria
The patient that a serious heart, liver, renal function disorder, a patient developing a malignant neoplasm, a gastrointestinal tract resection, stomach esophagus junction rebuilding art, a patient having the past of the straying neurolysis, the combination taboo medicine of VFT
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishihara Shinichi |
Organization
Ishihara Gastroenterology clinic
Division name
internalmedicine
Zip code
Address
1852-1,Ikano-cho,Zentsuji City.Kagawa
TEL
0877-63-6677
ccy63890@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishihara shinichi |
Organization
Ishihara Gastroenterology clinic
Division name
internalmedicine
Zip code
Address
1852-1,Ikano-cho,Zentsuji City.Kagawa
TEL
0877-63-6677
Homepage URL
ccy63890@yahoo.co.jp
Sponsor or person
Institute
Ishihara Gastroenterology clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021376
