UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Taste evaluation test for DNW-14012-001
Title of the study (Brief title)	Taste evaluation test for DNW-14012-001
Region	Japan

Condition
Condition	Chemotherapy-and/or radiation-induced oral mucositis
Classification by specialty	Radiology Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation for safety of GT-02037 in male healthy adult subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of threshold of saltiness by test paper (SALSAVE)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Single dose
Interventions/Control_2	Single dose
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	35 years-old >=
Gender	Male
Key inclusion criteria	Healthy male adult Body weight over 50 kg BMI over 18.5 under 25.0 kg/m2 Subjects without dysgeusia Nonsmokers Having given written informed consent prior to any procedure related to the study
Key exclusion criteria	Subjects using medical products Subjects who could start having allergic symptom in relation to test products Subjects with a disease of the oral mucous membrane (including a wound in the mouth) or subjects under dental treatment Subjects judged inappropriate for the study by the investigator
Target sample size	6

Research contact person
Name of lead principal investigator	Setsuo Hasegawa
Organization	Pharmaspur Inc.
Division name	Internal medicine
Address	1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6214-2670
Email	Setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person	Michiko Kainuma
Organization	Pharmaspur Inc.
Division name	Clinical study
Address	1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL	03-6214-2670
Homepage URL
Email	michiko_kainuma@pharmaspur.com

Sponsor
Institute	Pharmaspur Inc.
Institute
Department

Funding Source
Organization	National Cancer Centor Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 11 Day
Anticipated trial start date	2017 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2018 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034185