UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031306 |
|---|---|
| Receipt number | R000035456 |
| Scientific Title | Study of the ease of taking placebo formulations assuming an oral dosage form containing large amount of drug. |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2019/02/02 16:55:58 |
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Basic information
Public title
Study of the ease of taking placebo formulations assuming an oral dosage form containing large amount of drug.
Acronym
The ease of taking placebo formulation of large amount of drug.
Scientific Title
Study of the ease of taking placebo formulations assuming an oral dosage form containing large amount of drug.
Scientific Title:Acronym
The ease of taking placebo formulation of large amount of drug.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify differences of the ease of taking placebo formulations(powder,granule and micro-tablets) assuming an oral dosage form containing large amount of drugs.
Basic objectives2
Others
Basic objectives -Others
The ease of taking
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of water required for intake of tablets
Key secondary outcomes
Visual analogue scale
5-point scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
micro tablet
Interventions/Control_2
granule formulation
Interventions/Control_3
powder formulation
Interventions/Control_4
micro-tablets containing a bitterness material
Interventions/Control_5
granule containing a bitterness material
Interventions/Control_6
powder containing a bitterness material
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy 20-40 year-old volunteers(male and female)
Key exclusion criteria
1)People who have hardness for swallowing
2)People who have an extraordinary state in throat.
3)People who have allergy about citron or citrus fruits.
4)Other who was decided as inadequate by research contact person.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Namiki Noriyuki |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmacy Practice and Science
Zip code
Address
52-1, Yada, Suruga, Shizuoka
TEL
054-264-5237
namiki@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uchida Shinya |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmacy Practice and Science
Zip code
Address
52-1, Yada, Suruga, Shizuoka
TEL
054-264-5234
Homepage URL
uchidas@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
School of Pharmaceutical Sciences University of Shizuoka,Department of Pharmacy Practice and Science
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd
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
静岡県立大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 16 | 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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
