UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020989
Receipt number R000024230
Scientific Title Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study
Date of disclosure of the study information 2016/02/22
Last modified on 2018/02/14 15:29:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study

Acronym

Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH

Scientific Title

Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH: A three-way crossover study

Scientific Title:Acronym

Comparison of the effect of 20mg Vonoprazan,30mg,Lansoprazole and 20mg Famotidine on intragastric pH

Region

Japan


Condition

Condition

reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The ideal medication for treatment of acid related diseases should have a rapid onset of action to promote hemostasis and symptoms.
No studies have compared directly the intragastric pH of Vonoprazan that is a new class of proton pomp inhibitor (PPI), Lansoprazole and Famotidine

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intragastric pH by pH meter attached to the antimony pH electrode for 6 hour after administration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vonoprazan20mg-(washout period)-Lansoprazole30mg-(washout period)-Famotidine20mg

Interventions/Control_2

Lansoprazole30mg-(washout period)-Vonoprazan20mg-(washout period)-Famotidine20mg

Interventions/Control_3

Famotidine20mg-(washout period)-Lansoprazole30mg-(washout period)-Vonoprazan20mg

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

Key inclusion criteria

Patient who fills everything the following
1) Helicobacter pylori-negative male Patient
2) Patient of 20 years or more
3) Patient who gives written informed consent

Key exclusion criteria

The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Inamori

Organization

Yokohama City University School of Medicine

Division name

Department of Medical Education

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2626

Email

inamorim@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Iida

Organization

Yokohama City University School of Medicine

Division name

Department of Medical Education

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2800

Homepage URL


Email

hiro0905@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University School of Medicine Department of Medical Education

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

横浜市立大学医学部


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 22 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 02 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 03 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 02 Month 12 Day

Last modified on

2018 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=R000024230


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name