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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022589
Receipt No. R000026043
Scientific Title Evaluation of palartability of gummi drugscontained aripiprazole, epinastine, and ibpurofen
Date of disclosure of the study information 2016/06/03
Last modified on 2018/01/03

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Basic information
Public title Evaluation of palartability of gummi drugscontained aripiprazole, epinastine, and ibpurofen
Acronym Evaluation of palartability of gummi drugs.
Scientific Title Evaluation of palartability of gummi drugscontained aripiprazole, epinastine, and ibpurofen
Scientific Title:Acronym Evaluation of palartability of gummi drugs.
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We aimed to investigate the effects of flavour and sweetener on the palatability of gummi drugs contained aripiprazole, epinastine and ibprofen.
Basic objectives2 Others
Basic objectives -Others Evaluation of palatabilyty of pharmaceutical formulation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.palatability (visual analogue scale) in mouth.
2.palatability (visual analogue scale) after spatting out
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 7
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gummi drugs without flavours
Interventions/Control_2 Gummi drugs with flavour A
Interventions/Control_3 Gummi drugs with flavour B
Interventions/Control_4 Gummi drugs with flavour A and flavour B
Interventions/Control_5 Gummi drugs with flavour C
Interventions/Control_6 Gummi drugs with menthorl
Interventions/Control_7 Gummi drugs with flavor and menthol
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 adults (female and male) aged >=20 years old
Key exclusion criteria 1. clear taste disturbance
2. allegy for drugs
3. allegy for gelatin
4. pregnant woman and/or woman during lactation
5. Others who were decided as irrelevant 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 & Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan
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 & Therapeutics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan
TEL 053-435-2385
Homepage URL
Email hakamata@hama-med.ac.jp

Sponsor
Institute Department of Clinical Pharmacology & Therapeutics, Hamamatsu University School of Medicine
Institute
Department

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 Unpublished

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
2018 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026043

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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