UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003467 |
|---|---|
| Receipt number | 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 16:16:58 |
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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
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
maito@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Department of Gastroenterology and Metabolism
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
