UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022198
Receipt number R000025547
Scientific Title Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
Date of disclosure of the study information 2016/06/01
Last modified on 2019/02/14 19:17:07

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Basic information

Public title

Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Acronym

Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Scientific Title

Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Scientific Title:Acronym

Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy,rapidity and duration of acid-inhibitory effects of vonoprazan vs rabeprazole.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate that vonoprazan show a signifcant acid suppressant effect against rabeprazole by comparing an acid suppressant effect on gastric pH (pH holding time at no less than pH3, pH4, and pH5) between vonoprazan and rabeprazole

Key secondary outcomes

Acid suppressant effect by the CYP2C19 genetic polymorphism.
Nighttime acid suppressant effect.
An incidence of all adverse events.
Acid suppressant effect before and after a meal.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Subjects are administrated rabeprazole 20mg after administrated vonoprazan 20mg.

Interventions/Control_2

Subjects are administrated vonoprazan 20mg after administrated rabeprazole 20mg.

Interventions/Control_3

Subjects are administrated rabeprazole 40mg after administrated vonoprazan 20mg.

Interventions/Control_4

Subjects are administrated vonoprazan 20mg after administrated rabeprazole 40mg.

Interventions/Control_5

Subjects are administrated rabeprazole 20mg after administrated vonoprazan 10mg.

Interventions/Control_6

Subjects are administrated vonoprazan 10mg after administrated rabeprazole 20mg.

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

20 years of age or more

Key exclusion criteria

1) by constriction or deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion difficult.
2) there is a history of acid-related diseases.
3) there is a surgical history.
4) there is a history of radiation therapy to the upper abdomen.
5) serious complications(with heart failure, kidney failure, liver failure, respiratory failure).
6) Experience of oral administration of Vonoprazan or Rabeprazole.
7) there is a history of medication to up to one month before the registration date.
8) there is a history eradication of Helicobacter pylori.
9) Helicobacter pylori test positive (anti-HP IgG antibody, urease test, any one is positive urea breath test).
10) There is activity malignant tumor patients and other serious systemic complication.
11) there are abnormal findings in the upper gastrointestinal endoscopy.
12) F scale positive (total score 8 points or more)
13) There is a history of allergy to test drugs
14) pregnancy and lactation.
15) there is a plan of treatment with respect to the upper gastrointestinal tract disease.
16) there is a registration history in the study.
17) can not be obtained the consent to participate in this clinical study.
18) the study director (sharing) who doctor has determined to be inappropriate as a subject.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhide Higuchi

Organization

Osaka medical collage

Division name

second department of internal medicine

Zip code


Address

2-7, Daigakumachi, Takatsuki city, Osaka

TEL

0726831221

Email

taisyatyou3tyoume@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Kojima

Organization

Osaka medical collage

Division name

second department of internal medicine

Zip code


Address

2-7, Daigakumachi, Takatsuki city, Osaka

TEL

0726831221

Homepage URL


Email

in2134@osaka-med.ac.jp


Sponsor or person

Institute

Osaka medical collage

Institute

Department

Personal name



Funding Source

Organization

EA Pharma Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Gunma University,Yokohama City University,Hamamatsu University School of Medicine,Aichi Medical University,Osaka City University,Saga University,Oita University,University of Miyazaki,Shiga University of Medical Science,Okayama University

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

2016 Year 06 Month 01 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

Completed

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 01 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 05 Month 03 Day

Last modified on

2019 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name