UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029929 |
|---|---|
| Receipt number | R000034185 |
| Scientific Title | Taste evaluation test for DNW-14012-001 |
| Date of disclosure of the study information | 2017/11/11 |
| Last modified on | 2018/01/19 14:30:43 |
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Basic information
Public title
Taste evaluation test for DNW-14012-001
Acronym
Taste evaluation test for DNW-14012-001
Scientific Title
Taste evaluation test for DNW-14012-001
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Setsuo Hasegawa |
Organization
Pharmaspur Inc.
Division name
Internal medicine
Zip code
Address
1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL
03-6214-2670
Setsuo_hasegawa@pharmaspur.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Kainuma |
Organization
Pharmaspur Inc.
Division name
Clinical study
Zip code
Address
1-2-10 Nihonbashi,Chuo-ku,Tokyo,Japan
TEL
03-6214-2670
Homepage URL
michiko_kainuma@pharmaspur.com
Sponsor or person
Institute
Pharmaspur Inc.
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 10 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034185
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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