UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023795
Receipt number R000026929
Scientific Title English
Date of disclosure of the study information 2016/08/31
Last modified on 2017/03/01 23:09:13

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Basic information

Public title

English

Acronym

English

Scientific Title

English

Scientific Title:Acronym

English

Region

Japan


Condition

Condition

swallowing function

Classification by specialty

Oto-rhino-laryngology Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

English

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hearing

Key secondary outcomes

EMG


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

A group: schedule of swallowing capsules
1. Water
2. Capsule with water
3. Magic jelly
4. Capsule with magic jelly

Interventions/Control_2

B group: schedule of swallowing capsules
1. Magic jelly
2. Capsule with magic jelly
3. Water
4. Capsule with water

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

English

Key exclusion criteria

English

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maki Yoneko

Organization

Medical and Health Resources Research Institute

Division name

Director

Zip code


Address

4-38-7, Higashi-Ikebukuro, Toshiba-ku, Tokyo 170-0013, Japan

TEL

03-5904-8534

Email

research@mhrri.com


Public contact

Name of contact person

1st name
Middle name
Last name Maki Yoneko

Organization

Medical and Health Resources Research Institute

Division name

Research section

Zip code


Address

4-38-7, Higashi-Ikebukuro, Toshiba-ku, Tokyo 170-0013, Japan

TEL

03-5904-8534

Homepage URL


Email

research@mhrri.com


Sponsor or person

Institute

Medical and Health Resources Research Institute

Institute

Department

Personal name



Funding Source

Organization

Ryukakusan Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

東京都立産業技術研究センター


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 31 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

2016 Year 08 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 31 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 08 Month 28 Day

Last modified on

2017 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name