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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016460
Receipt No. R000019118
Scientific Title Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg.
Date of disclosure of the study information 2015/02/07
Last modified on 2015/05/01

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Basic information
Public title Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg.
Acronym Evaluation of gastric pH changes after administration of H2 blocker
Scientific Title Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg.
Scientific Title:Acronym Evaluation of gastric pH changes after administration of H2 blocker
Region
Japan

Condition
Condition Gastric Ulcer
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate gastric pH changes after administration of famotidine (10mg and 20mg) , 2 x 2 cross over study .
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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 To administer oral dose of famotidine (10mgg) and monitor gastric pH for 24 hours
Interventions/Control_2 To administer oral dose of famotidine (20mg) 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 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanari Shiramoto
Organization Medical Co. LTA 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 092-283-7701
Email masanari-shiramoto@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Masanari Shiramoto
Organization Medical Co. LTA 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 092-283-7701
Homepage URL
Email masanari-shiramoto@lta-med.com

Sponsor
Institute Medical Co. LTA Hakata Clinic
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
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
2015 Year 02 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
2015 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 07 Day
Last follow-up date
2015 Year 07 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
2015 Year 02 Month 06 Day
Last modified on
2015 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019118

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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