UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018216 |
|---|---|
| Receipt number | R000021089 |
| Scientific Title | Safety Evaluation of Phosphate-Binding Chewing Gum (food) for single over-intake and continuous intake in healthy adult. |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2023/01/10 09:11:54 |
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Basic information
Public title
Safety Evaluation of Phosphate-Binding Chewing Gum (food) for single over-intake and continuous intake in healthy adult.
Acronym
Safety Evaluation of Phosphate-Binding Chewing Gum (food) for single over-intake and continuous intake in healthy adult.
Scientific Title
Safety Evaluation of Phosphate-Binding Chewing Gum (food) for single over-intake and continuous intake in healthy adult.
Scientific Title:Acronym
Safety Evaluation of Phosphate-Binding Chewing Gum (food) for single over-intake and continuous intake in healthy adult.
Region
| Japan |
Condition
Condition
general adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of Phosphate-Binding Chewing Gum for 14 days and single over-intake in healthy adult.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
there is no change related to gastrointestinal symptoms before and after continuous and single over-intake test
Key secondary outcomes
Blood biochemistry test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous ingestion of the test product for 14 days
Ingestion of the test product for 3-fold quantity of recommended intake
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females with no-history of chronic gastrointestinal disease
Healthy males and females with no- medical products in study period
Healthy males and females aged 20 to 60 years old
Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | KANNO |
Organization
Tokyo Medical University
Division name
Department of Nephrology
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo
TEL
03-3342-6111
kannoyh@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Murakami |
Organization
Kissei Pharmaceutical Co.Ltd
Division name
Nutritional business center
Zip code
3990711
Address
9637-6 kataoka,shiojiri-City, Nagano-Pref.399-0711,Japan
TEL
0263-54-5010
Homepage URL
tsutomu_murakami@pharm.kissei.co.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagawa Nutrition University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee for medical ethics
Address
6-7-1 Nishishinjuku Tokyo
Tel
0333426111
irb@tokyo-med.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
| 2015 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Unpublished
Result
URL related to results and publications
n/a
Number of participants that the trial has enrolled
0
Results
Not carried out
Results date posted
| 2023 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
Not evaluated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021089
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
