UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038418 |
|---|---|
| Receipt number | R000043779 |
| Scientific Title | Survey on oral coloration when taking orally disintegrating tablets in patients with Parkinson's disease |
| Date of disclosure of the study information | 2019/11/20 |
| Last modified on | 2020/04/28 09:37:14 |
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Basic information
Public title
Survey on oral coloration when taking orally disintegrating tablets in patients with Parkinson's disease
Acronym
Survey on oral coloration
Scientific Title
Survey on oral coloration when taking orally disintegrating tablets in patients with Parkinson's disease
Scientific Title:Acronym
Survey on oral coloration when taking orally disintegrating tablets in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If the drug is colored in the oral cavity, consider whether it will interfere with treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score on the desire to take orally disintegrating tablets
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
1) Patients with Parkinson's disease who are hospitalized or going to Showa University Hospital East Hospital
2) Patients who are over 20 years old when obtaining consent
3) Patients who can take internal medicine by themselves
4) Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients judged to be ineligible at the discretion of the researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | HIDA |
Organization
Showa university
Division name
School of medicine
Zip code
1578577
Address
6-11-11, Kitakarasuyama, setagaya-ku, tokyo
TEL
03-3300-5254
n.hida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | HIDA |
Organization
Showa university
Division name
school of medicine
Zip code
1578577
Address
6-11-11, Kitakarasuyama, setagaya-ku, tokyo
TEL
03-3300-5254
Homepage URL
n.hida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa university
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
Showa Univ. IRB
Address
1-5-8, Hatanodai, Shinagawaw-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.jp
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
| 2019 | Year | 11 | Month | 20 | 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
| 2019 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Questionnaire survey on color tone of tongue after taking orally disintegrating tablets
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043779
| 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 |
