UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023293 |
|---|---|
| Receipt number | R000026850 |
| Scientific Title | Effect on intestinal bacterial flora of the proton pump inhibitor in the nonsteroidal antiinflammatory drug chronic administration |
| Date of disclosure of the study information | 2016/07/30 |
| Last modified on | 2019/03/22 17:15:12 |
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Basic information
Public title
Effect on intestinal bacterial flora of the proton pump inhibitor in the nonsteroidal antiinflammatory drug chronic administration
Acronym
The effect that combination of NSAID and PPI gives to enteric bacteria
Scientific Title
Effect on intestinal bacterial flora of the proton pump inhibitor in the nonsteroidal antiinflammatory drug chronic administration
Scientific Title:Acronym
The effect that combination of NSAID and PPI gives to enteric bacteria
Region
| Japan |
Condition
Condition
NSAIDs induced small intestinal injury
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Are changes of the intestinal bacterial flora causing the NSAIDs induced small intestinal injury different in esomeprazole and vonoprazan?
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of the intestinal bacterial flora
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
A group (esomeprazole 20mg/day).We obtain 5 g of stool .180 days after .90 days later assignment 30 days before assignment later and measure enteric bacteria by the T-RFLP method.
Interventions/Control_2
B group in (vonoprazan 10mg/day)).We obtain 5 g of stool .180 days after .90 days later assignment 30 days before assignment later and measure enteric bacteria by the T-RFLP method.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PPI that continued NSAIDs and LDA, and took and an H2 receptor blocker or older
Key exclusion criteria
patients with a serious complication [hepatic disorder, renal disease, heart disorder, blood disorder, metabolic disorders or malignant tumor] is pregnant or hope for pregnancy during study period with the history allergic to PPI and nursing mother and others, a researcher are inadequacy and the patients who judged it
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihisa Takeuchi |
Organization
Osaka Medical Collage
Division name
Depertment of 2nd. internal medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan
TEL
0726831221
in2097@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Takeuchi |
Organization
Osaka Medical Collage
Division name
Depertment of 2nd. internal medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki-shi, Osaka, Japan
TEL
0726831221
Homepage URL
in2097@osaka-med.ac.jp
Sponsor or person
Institute
Depertment of 2nd. internal medicine, Osaka Medical Collage
Institute
Department
Personal name
Funding Source
Organization
Depertment of 2nd. internal medicine, Osaka Medical Collage
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
| 2016 | Year | 07 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026850
