UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013379
Receipt number R000015610
Scientific Title Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. Study1:To investigate timing of PPI single dose. Study2:To investigate dose frequency of H2 blocker.
Date of disclosure of the study information 2014/03/10
Last modified on 2014/08/19 17:21:49

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Basic information

Public title

Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
Study1:To investigate timing of PPI single dose.
Study2:To investigate dose frequency of H2 blocker.

Acronym

Evaluation of gastric pH changes after administration of PPI or H2 blocker.

Scientific Title

Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
Study1:To investigate timing of PPI single dose.
Study2:To investigate dose frequency of H2 blocker.

Scientific Title:Acronym

Evaluation of gastric pH changes after administration of PPI or H2 blocker.

Region

Japan


Condition

Condition

Gastric Ulcer

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Study1:
To investigate the influence of timing of PPI single dose confirming changes in 24 hour gastric pH, 2 x 2 cross over study.
Study2:
To investigate the influence of dose frequency of H2 blocker confirming changes in 24 hour gastric pH, 2 x 2 cross over study.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Study1:
24 hour intragastric pH after administration of sodium rabeprazole
Study2:
24 hour intragastric pH and pharmacokinetics after administration of famotidine.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Study1:
To administer oral dose of sodium rabeprazole and monitor gastric pH for 24 hours.

Interventions/Control_2

Study2:
To administer oral dose of famotidine and monitor gastric pH for 24 hours.

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

40 years-old >=

Gender

Male

Key inclusion criteria

1, Healthy Japanese male subjects who provide signed written informed consent.
2, Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3, Subjects with BMI <=18.5 and >25.0 at the time of screening.
4, Subjects judged as adequate for this study by study physician.

Key exclusion criteria

1, Subjects with present illness which requires treatment.
2, Subjects with past medical history which was considered not adequate for this study.
3, Subjects with past history of drug allergy.
4, Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission of period 1.
5. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1.
6, Subjects who participated in a clinical trial and was administered study drug.
7, Subjects with history of alcohol and/or drug abuse.
8, Subjects who was judged not appropriate for this study by study physician.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanari Shiramoto

Organization

Medical Co. LTA
Clinical Pharmacology Center
Hakata Clinic

Division name

Clinical Pharmacology Department

Zip code


Address

Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan

TEL

0922837701

Email

masanari-shiramoto@lta-med.com


Public contact

Name of contact person

1st name
Middle name
Last name Masanari Shiramoto

Organization

Medical Co. LTA Clinical Pharmacology Center Hakata Clinic

Division name

Clinical Pharmacology Department

Zip code


Address

Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan

TEL

0922837701

Homepage URL


Email

masanari-shiramoto@lta-med.com


Sponsor or person

Institute

Medical Co. LTA
Clinical Pharmacology Center

Institute

Department

Personal name



Funding Source

Organization

Towa pharmaceutical co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Towa pharmaceutical co., LTD.

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

2014 Year 03 Month 10 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

2014 Year 03 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 10 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

2014 Year 03 Month 10 Day

Last modified on

2014 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015610


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name