UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005300 |
|---|---|
| Receipt number | R000006304 |
| Scientific Title | A study on the prevalence of diarrhea associated with proton pump inhibitors (PPIs) |
| Date of disclosure of the study information | 2011/03/24 |
| Last modified on | 2013/03/26 09:05:35 |
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Basic information
Public title
A study on the prevalence of diarrhea associated with proton pump inhibitors (PPIs)
Acronym
A study on the prevalence of diarrhea associated with proton pump inhibitors (PPIs)
Scientific Title
A study on the prevalence of diarrhea associated with proton pump inhibitors (PPIs)
Scientific Title:Acronym
A study on the prevalence of diarrhea associated with proton pump inhibitors (PPIs)
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease and gastroduodenal ulcer etc.
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarified the risk of diarrhea caused by three kinds of PPIs; lansoprazole, rabeprazole, and omeprazole.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
daily stool frequency, stool consistency using Bristol Stool Scale Form, and impaired QOL caused by diarrhea for one month
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
outpatients who have been taking PPIs for over one month
Key exclusion criteria
patients who are diagnosed as irritable bowel syndrome, who take drug for constipation, and who take PPI on-demand basis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University School of Medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
Enya-cho 89-1, Izumo-shi, Shimane 693-8501, Japan
TEL
Homepage URL
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
島根大学医学部附属病院（島根県）、はまもと内科クリニック（島根県）、よしの医院（島根県）、医療法人園山医院（島根県）、松江赤十字病院（島根県）、島根県立中央病院（島根県）、出雲市総合医療センター（島根県）、玉造厚生年金病院（島根県）、小野市民病院（兵庫県）、鳥取市立病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2011 | Year | 03 | Month | 24 | Day |
Last modified on
| 2013 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006304
| Research Plan | |
|---|---|
| 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 |
