UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029714 |
|---|---|
| Receipt number | R000033956 |
| Scientific Title | Analysis of the relationship between rheological parameters and sensory evaluation of heparin-containing preparations |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/10/29 11:05:49 |
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Basic information
Public title
Analysis of the relationship between rheological parameters and sensory evaluation of heparin-containing preparations
Acronym
Analysis of the relationship between rheological parameters and sensory evaluation of heparin-containing preparations
Scientific Title
Analysis of the relationship between rheological parameters and sensory evaluation of heparin-containing preparations
Scientific Title:Acronym
Analysis of the relationship between rheological parameters and sensory evaluation of heparin-containing preparations
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usability required for topical external pharmaceutical formulations containing heparin analogues
Basic objectives2
Others
Basic objectives -Others
Scientific basis for selecting dosage forms based on usability such as physiological and sensory characteristics
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensory evaluation on usability
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
Apply approximately 250 mg to normal skin once to give a circle with a diameter of about 5 cm (area 19.5 cm^2).
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
| 22 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Be able to acquire consent in writing by the principal concerning participation in the exam.
2.Regardless of age and sex.
3.Before starting the study, you should not receive external medication containing heparin analogue.
Key exclusion criteria
1.Hemorrhagic hematologic disorder (haemophilia, thrombocytopenia, purpura etc) must be present.
2.It is expected that even a slight bleeding will have serious consequences.
3.Person who has a history of hypersensitivity to heparin analogue.
4.A woman who may be pregnant.
5.Person who are applying steroid drugs.
6.Person who have judged that the research director is inappropriate as the object of this examination.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toyofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University, School of Pharmacy
Division name
Laboratory of Pharmaceutics
Zip code
2748555
Address
7-7-1 Narashinodai, Funabashi, Chiba 274-8555, Japan
TEL
0474655877
suzuki.toyofumi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyofumi |
| Middle name | |
| Last name | Suzuki |
Organization
Nihon University, School of Pharmacy
Division name
Laboratory of Pharmaceutics
Zip code
2748555
Address
7-7-1 Narashinodai, Funabashi, Chiba 274-8555, Japan
TEL
0474655877
Homepage URL
suzuki.toyofumi@nihon-u.ac.jp
Sponsor or person
Institute
Laboratory of Pharmaceutics, Nihon University, School of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Laboratory of Pharmaceutics, Nihon University, School of Pharmacy
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
School of Pharmacy, Nihon University
Address
7-7-1 Narashinodai, Funabashi, Chiba 274-8555, Japan
Tel
0474655877
suzuki.toyofumi@nihon-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
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
47
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In preparation
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
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033956
| Research Plan | |
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| 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 |
