UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of clinical disintegration time and palatability of orally disintegrating tablets of rebamipide
Title of the study (Brief title)	Evaluation of clinical disintegration time and palatability of orally disintegrating tablets of rebamipide
Region	Japan

Condition
Condition	Healhy volunteea
Classification by specialty	Medicine in general Gastroenterology 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) 3. acceptableness
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	5
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rebamipide ODT without taste-masking
Interventions/Control_2	rebamipide ODT with sweeteners
Interventions/Control_3	rebamipide ODT with sweeteners and cocoa powder(2.5%)
Interventions/Control_4	rebamipide ODT with sweeteners and cocoa powder(5%)
Interventions/Control_5	rebamipide ODT with sweeteners and cocoa powder(10%)
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	Hiroshi Watanabe
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Email	hwt@hama-med.ac.jp

Public contact
Name of contact person	Akio Hakamata
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapetics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Homepage URL
Email	hakamata@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Shool of Pharmaceutical Science, Department of Pharmacy Practice & Science, University of Shizuoka
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shool of Pharmaceutical Science, Department of Pharmacy Practice & Science, University of Shizuoka
Name of secondary funｄer(s)

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 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 03 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026942