UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002111 |
|---|---|
| Receipt number | R000002574 |
| Scientific Title | Effect of proton pump inhibitor pretreatment for eradication of helicobacter pylori. |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2016/03/09 16:33:50 |
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Basic information
Public title
Effect of proton pump inhibitor pretreatment for eradication of helicobacter pylori.
Acronym
Effect of proton pump inhibitor pretreatment for eradication of helicobacter pylori.
Scientific Title
Effect of proton pump inhibitor pretreatment for eradication of helicobacter pylori.
Scientific Title:Acronym
Effect of proton pump inhibitor pretreatment for eradication of helicobacter pylori.
Region
| Japan |
Condition
Condition
Patient with gastrointestinal ulcer and helicobacter pylori positive.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Some study show that proton pump inhibitor pretreatment for eradication of helicobacter pylori does not affect the result. The proton pump inhibitor pretreatment for eradication of helicobacter pylori is useful for improvement of subjective symptoms. We study whether the proton pump inhibitor pretreatment for eradication of helicobacter pylori affect quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Omeplazole 20mg pre eradication
Interventions/Control_2
Omeplazole 20mg post eradication
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who fills everything the following
1) Helicobacter pylori-positive patient has ulcer.
2) Patient of 20 years or more
3) Patient who gives written informed consent
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
2) Subjects with malignancy
3)Others
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | 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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | 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
| 2009 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002574
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
