UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030831 |
|---|---|
| Receipt number | R000034780 |
| Scientific Title | Evaluation of the disolution and palatability of amlodipine orally disintegrating tablet in oral cavity for development of quantitative evaluation methods of palatability by an electronic gustatory system |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2019/02/02 16:55:25 |
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Basic information
Public title
Evaluation of the disolution and palatability of amlodipine orally disintegrating tablet in oral cavity for development of quantitative evaluation methods of palatability by an electronic gustatory system
Acronym
Disolution in the oral cavity and palatability of amlodipine orally disintegrating tablet
Scientific Title
Evaluation of the disolution and palatability of amlodipine orally disintegrating tablet in oral cavity for development of quantitative evaluation methods of palatability by an electronic gustatory system
Scientific Title:Acronym
Disolution in the oral cavity and palatability of amlodipine orally disintegrating tablet
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the elution behavior in the oral cavity and palatability of amlodipine (5 mg) orally disintegrating tablets (ODTs) with physical and gustatory masking for clarifying the effects of physical and gustatory masking
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate the relationship between
1. The elution volume of amlodipine in the oral cavity and in vitro studies
2.The clinical VAS scores of palatability in the human gustatory sensation test and the electronic gustatory system
for verifying the validity of quantitative evaluation methods of palatability by an electronic gustatory system
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the clinical VAS scores of palatability in the human gustatory sensation test and the electronic gustatory system
Key secondary outcomes
Elution volume of amlodipine in the oral cavity
Saliva volume
VAS score(overall palatability)
VAS score(bitterness/sweetness)
5-point scale(palatability)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
COAO:Amlodipine ODT without taste-masking
Interventions/Control_2
C4A0:Physical masking(4%) of Amlodipine ODT
Interventions/Control_3
C6A0:Physical masking(6%) of Amlodipine ODT
Interventions/Control_4
C6A2:Physical masking(6%) of Amlodipine ODT with a sweetener(2%)
Interventions/Control_5
C6A4:Physical masking(6%) of Amlodipine ODT with a sweetener(4%)
Interventions/Control_6
C10A0: Physical masking(10%) of Amlodipine ODT
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
1. Clearly taste disorder
2. Allergy for drugs
3. Pregnant and/or lactating women
4. Other who was decided as inadequate by doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Inui |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
inui@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Kamiya |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
ilka122@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was supported by JSPS KAKENHI Grant Number JP17K08454.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka
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
浜松医科大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | 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
| 2018 | Year | 01 | Month | 16 | Day |
Last modified on
| 2019 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034780
