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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031306
Receipt No. 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

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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
Email 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
Email uchidas@u-shizuoka-ken.ac.jp

Sponsor
Institute School of Pharmaceutical Sciences University of Shizuoka,Department of Pharmacy Practice and Science
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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