UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of swallowing reflex promoting effect due to capsaicin intake for swallowing disorders of the nervous intractable disease patient
Title of the study (Brief title)	The swallowing reflex promoting effect of nerve intractable disease patients with capsaicin
Region	Japan

Condition
Condition	Neurodegenerative disease
Classification by specialty	Neurology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Even for neurodegenerative disease, will be verified to have a swallowing reflex promotion due to the intake in the same manner as in capsaicin-containing film and the healthy and elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	Eliciting time of swallowing reflex
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	In After ingesting capsaicin-containing wafers film, to measure the swallowing reflex induction time
Interventions/Control_2	In After wafers film, to measure the swallowing reflex induction time
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Neurodegenerative disease Communicate possible Possible move to the laboratory
Key exclusion criteria	If not possible communicate Bronchial asthma, those with chronic cough Women of childbearing potential If the tracheotomy mounting of Kanyure Person attending physician determines that it is difficult to securely enforce the study
Target sample size	40

Research contact person
Name of lead principal investigator	Naomichi Murata
Organization	Okayama University Hospital
Division name	the Center for special needs dentistry
Address	2-5-1 Shikata-cho Kita-ku Okayama city
TEL	086-235-6823
Email	murata-n@md.okayama-u.ac.jp

Public contact
Name of contact person	Higashi Tomoko
Organization	Okayama University Hospital
Division name	he Center for special needs dentistry
Address	2-5-1 Shikata-cho Kita-ku Okayama city
TEL	086-235-6823
Homepage URL
Email	murata-n@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 11 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	2015 Year 10 Month 05 Day
Last modified on	2018 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022240