UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031986 |
|---|---|
| Receipt number | R000035712 |
| Scientific Title | Evaluation of palatability of newly developed fast disintegrating tablet of Kremezin in patient. |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2019/02/02 16:56:25 |
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Basic information
Public title
Evaluation of palatability of newly developed fast disintegrating tablet of Kremezin in patient.
Acronym
Evaluation of palatability of Kremezin tablet.
Scientific Title
Evaluation of palatability of newly developed fast disintegrating tablet of Kremezin in patient.
Scientific Title:Acronym
Evaluation of palatability of Kremezin tablet.
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To carify the palataboility of fast disintegrating tablet of kremezin.
Basic objectives2
Others
Basic objectives -Others
Adherence of taking medicines.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Palatability of fast disintegrating tablet of kremezin
Key secondary outcomes
Overall adherence for all medicine prescrived.
Adherence for Kremezin formulations.
Changes of body weight, BUN, s-Cre and eGFR
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20-80 year-old patients(male and female)
Patients who have taken kremezin fine grain at the time of the first questionnaire and have taken medication of it for more than 1 month
Patients who give the singed informed consent.
Key exclusion criteria
Patients who apply to administration contraindications in the package insert of kremezin
Patients who will not see the outpatients clinic within 2 weeks to 2 months
Patients who can not communicate due to cognitive deterioration
Patients who do not manage medication by themselves and their families
Patients who it is hard to swallow
Patients who have extraordinary state in oral cavity.
Patients who is considered as imappropriate by doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Namiki Noriyuki |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmaceutical Science
Zip code
Address
52-1, Yada, Suruga, Shizuoka
TEL
054-264-5237
namiki@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uchida Shinya |
Organization
School of Pharmaceutical Sciences University of Shizuoka
Division name
Department of Pharmaceutical Science
Zip code
Address
52-1, Yada, Suruga, Shizuoka
TEL
054-264-5234
Homepage URL
uchidas@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
School of Pharmaceutical Sciences University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
医療法人 優雅 東林間かねしろ内科クリニック
医療法人 優雅 鶴間かねしろ内科クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 30 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey (palatability and adhereance) are perfomed to patients who are prescrived fast disintegrating tablets of Kremnezin changed from the fine granule formulation. After 14 days to 2 months, same questionnaire survey (palatability and adhereance) will be perfomed.
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | 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=R000035712
