UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007620 |
|---|---|
| Receipt number | R000008993 |
| Scientific Title | Effect of aripiprazole on swallowing function |
| Date of disclosure of the study information | 2012/04/30 |
| Last modified on | 2016/10/03 11:45:29 |
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Basic information
Public title
Effect of aripiprazole on swallowing function
Acronym
Aripiprazole and swallowing function
Scientific Title
Effect of aripiprazole on swallowing function
Scientific Title:Acronym
Aripiprazole and swallowing function
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aspiration is a major risk factor for pneumonia. We have previously reported that a use of neuroleptics depresses swallowing function and might be a risk for aspiration pneumonia. Aripiprazole is a partial agonist of dopamine D2 receptor and might not be a risk for aspiration pneumonia. We therefore examine the effect of apripiprazloe on the swallowing function in patients with schizophrenia.
Basic objectives2
Others
Basic objectives -Others
We study the other symptoms than swallowing function.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
We perform swallowing tests and measure swallowing latency in selected patients before and after administration of aripiprazole.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We perform swallowing tests and record the swallowing latency before and after administration of aripiprazole in schizophrenia patients with symptoms or signs of aspiration.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible are schizophrenia patients older than 30 years having symptoms or signs of aspiration.
Key exclusion criteria
We exclude patients with delirium and infections.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ohrui |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Division of Geriatric Pharmacotherapy
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, Japan
TEL
022-717-8480
ohruit@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ohrui |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Division of Geriatric Pharmacotherapy
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai, Japan
TEL
022-717-8480
Homepage URL
ohruit@idac.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Institute of Development, Aging and Cancer, Tohoku University
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
東北大学病院（Tohoku University Hospital）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 08 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 08 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008993
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
