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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name