UMIN-CTR Clinical Trial

Public title

Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
-Evaluation of gastric pH changes after administration of PPI-

Acronym

Evaluation of gastric pH changes after administration of PPI.

Scientific Title

Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
-Evaluation of gastric pH changes after administration of PPI-

Scientific Title:Acronym

Evaluation of gastric pH changes after administration of PPI.

Region

Japan

Condition

Healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To see the changes in 24 hour gastric pH after oral administration of gastric secretion inhibiter, 2 x 2 cross over study, under fasted and fed condition.

Basic objectives2

PK,PD

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

24 hour gastric pH and pharmacokinetics after administration of sodium rabeprazole

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To administer oral dose of sodium rabeprazole

Interventions/Control_2

To 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

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 identified as CYP2C19 heterozygous extensive metabolizer or poor metabolizer
4, Subjects with BMI <=18.5 and >25.0 at the time of screening.
5, 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 administration 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 administration of period 1.
6, Subjects who participated in a clinical trial and was administered study drug within 4 months prior to administration of period 1.
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

12

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

Email

Name of contact person

1st name
Middle name
Last name

Organization

Medical co. LTA Clinical Pharmacology Center, Hakata Clinic

Division name

Clinical Pharmacology Department

Zip code

Address

TEL

0922837701

Homepage URL

Email

Institute

Medical Co. LTA Clinical Pharmacology Center

Institute

Department

Personal name

Organization

Towa Pharmaceutical co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Towa Pharmaceutical co., LTD.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人相生会　博多クリニック（福岡県）

Date of disclosure of the study information

2012

Year

04

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

03

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

01

Day

Last follow-up date

2012

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

04

Month

06

Day

Last modified on

2012

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009053