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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003467
Receipt No. R000004195
Scientific Title Effect of laftidine on Helicobacter pylori test: crossover comaparison with proton pump inhibitor
Date of disclosure of the study information 2010/07/01
Last modified on 2011/04/12

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Basic information
Public title Effect of laftidine on Helicobacter pylori test: crossover comaparison with proton pump inhibitor
Acronym Effect of laftidine on Helicobacter pylori
Scientific Title Effect of laftidine on Helicobacter pylori test: crossover comaparison with proton pump inhibitor
Scientific Title:Acronym Effect of laftidine on Helicobacter pylori
Region
Japan

Condition
Condition Health adult volunteer with Hp infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of anti-secretary agents on Hp test.
Basic objectives2 Others
Basic objectives -Others Influence on laboratory tests
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Influence on test results of Hp
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 No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Laftidine 10mg twice daily for 14 days
Interventions/Control_2 Lansoprazole 30mg once daily for 14 days
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
65 years-old >
Gender Male and Female
Key inclusion criteria Healthy adult volunteer with Hp infection
Key exclusion criteria 1) Subjects with hyper sensitivity for laftidine pr lansoprazole
2) Subjects who are taking Atazanavir Sulfate
3) Subjects with hepatic or renal failure , or subjects under renal hemodialysis
4) Subjects older than 65
5) subjects with history of digestive tract resection or vagotomy
6) Subjects who were taking H2-blocker or PPI within 2 weeks
7) Subjects with serious disease such as neoplasm
8) Pregnant, parturient and/or lactating women having a potential of pregnancy
9) Subjects with hyper sensitivity for any druds
10) Subjects who were considered ineligible by the investigator for other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Tanaka
Organization Hiroshima University Hospital
Division name Department of Endoscopy
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL +81-82-257-5538
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Ito
Organization Hiroshima University Hospital
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL +81-82-257-5191
Homepage URL
Email maito@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital, Department of Gastroenterology and Metabolism
Institute
Department

Funding Source
Organization Hiroshima University Hospital, Department of Gastroenterology and Metabolism
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 広島大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 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 Terminated
Date of protocol fixation
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 04 Month 09 Day
Last modified on
2011 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004195

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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