UMIN-CTR Clinical Trial

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
Email	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
Email	suzuki.toyofumi@nihon-u.ac.jp

Sponsor
Institute	Laboratory of Pharmaceutics, Nihon University, School of Pharmacy
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033956