UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022590
Receipt number R000026042
Scientific Title Evaluation of disintegration time and palatability of mitigulinide orally disintegrating tablet.
Date of disclosure of the study information 2016/06/03
Last modified on 2016/06/03 11:10:55

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Basic information

Public title

Evaluation of disintegration time and palatability of mitigulinide orally disintegrating tablet.

Acronym

Evaluation of disintegration time and palatability of mitigulinide orally disintegrating tablet.

Scientific Title

Evaluation of disintegration time and palatability of mitigulinide orally disintegrating tablet.

Scientific Title:Acronym

Evaluation of disintegration time and palatability of mitigulinide orally disintegrating tablet.

Region

Japan


Condition

Condition

Healhy volunteea

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aime of this study is to examine the effect of organoleptic and physical masking of mitigline orally disintegrating tablets.

Basic objectives2

Others

Basic objectives -Others

Gustatory sensation tests

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. disintegration time
2. palatability (visual analogue scale)

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

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

mitiglinide ODT without taste-masking

Interventions/Control_2

physical masking of mitiglinide ODT

Interventions/Control_3

physical masking of mitiglinide ODT with a sweetener

Interventions/Control_4

physical masking mitiglinide ODT with a sweetener and flavor

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


Not applicable

Gender

Male and Female

Key inclusion criteria

healthy adult (male and female)

Key exclusion criteria

1. clearly taste disorder
2. allegy for drugs
3. pregnant and/or lactating women
4. other who was decided as inadequate by doctor

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Watanabe

Organization

Hamamatsu University School of Medicine

Division name

Department of Clinical Pharmacology and Therapetics

Zip code


Address

1-20-1, Hanadayama, Higashi-ku, Hamamatsu

TEL

053-435-2385

Email

hwat@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akio Hakamata

Organization

Hamamatsu University School of Medicine

Division name

Department of Clinical Pharmacology and Therapetics

Zip code


Address

1-20-1, Hanadayama, Higashi-ku, Hamamatsu

TEL

053-435-2385

Homepage URL


Email

hakamata@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka

Organization

Division

Category of Funding Organization

Self funding

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)

Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka


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



Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 03 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

2015 Year 10 Month 07 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 07 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

2016 Year 06 Month 03 Day

Last modified on

2016 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026042


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name