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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007678
Receipt No. R000009053
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-
Date of disclosure of the study information 2012/04/07
Last modified on 2012/07/17

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Basic information
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
Condition Healthy male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
Primary outcomes 24 hour gastric pH and pharmacokinetics after administration of sodium rabeprazole
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 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

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 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

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
Email

Public contact
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

Sponsor
Institute Medical Co. LTA Clinical Pharmacology Center
Institute
Department

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 医療法人相生会 博多クリニック(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 07 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
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
Other related information

Management information
Registered date
2012 Year 04 Month 06 Day
Last modified on
2012 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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