UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019243
Receipt number R000022240
Scientific Title Study of swallowing reflex promoting effect due to capsaicin intake for swallowing disorders of the nervous intractable disease patient
Date of disclosure of the study information 2015/11/01
Last modified on 2018/10/17 10:26:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of swallowing reflex promoting effect due to capsaicin intake for swallowing disorders of the nervous intractable disease patient

Acronym

The swallowing reflex promoting effect of nerve intractable disease patients with capsaicin

Scientific Title

Study of swallowing reflex promoting effect due to capsaicin intake for swallowing disorders of the nervous intractable disease patient

Scientific Title:Acronym

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

1st name
Middle name
Last name Naomichi Murata

Organization

Okayama University Hospital

Division name

the Center for special needs dentistry

Zip code


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

1st name
Middle name
Last name Higashi Tomoko

Organization

Okayama University Hospital

Division name

he Center for special needs dentistry

Zip code


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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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)



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

2015 Year 11 Month 01 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

No longer recruiting

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name