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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name