UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002240 |
|---|---|
| Receipt number | R000002744 |
| Scientific Title | Therapeutic effect of mosapride and lansoprazole for the prevention of aspiration pnumonia in patiets treated by gastrostomy feeding |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2010/08/12 09:40:38 |
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Basic information
Public title
Therapeutic effect of mosapride and lansoprazole for the prevention of aspiration pnumonia in patiets treated by gastrostomy feeding
Acronym
Prevention of aspiration pnumonia
Scientific Title
Therapeutic effect of mosapride and lansoprazole for the prevention of aspiration pnumonia in patiets treated by gastrostomy feeding
Scientific Title:Acronym
Prevention of aspiration pnumonia
Region
| Japan |
Condition
Condition
patients treated by gastrostomy feeding
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
establishment of the method to prevent aspiration pnumonia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurence of aspiration pnumonia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
mosapride administration
Interventions/Control_2
lansoprazole administration
Interventions/Control_3
control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with chronic gastritis and esophagitis who are treated by gastrostomy feeding
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University
Division name
Dept of Internal Medicine II
Zip code
Address
89-1,Enya, Izumo-shi
TEL
0853-20-2190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
Dept of Medicine II
Zip code
Address
TEL
0853-20-2190
Homepage URL
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
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 | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | 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 | 07 | Month | 23 | Day |
Last modified on
| 2010 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002744
