UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015278
Receipt number R000017766
Scientific Title Epicutaneous and / or intralymphatic immunotherapy for nasal allergy
Date of disclosure of the study information 2014/10/01
Last modified on 2014/10/01 12:56:34

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Basic information

Public title

Epicutaneous and / or intralymphatic immunotherapy for nasal allergy

Acronym

Epicutaneous and / or intralymphatic immunotherapy

Scientific Title

Epicutaneous and / or intralymphatic immunotherapy for nasal allergy

Scientific Title:Acronym

Epicutaneous and / or intralymphatic immunotherapy

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to investigate the efficacy and safty for Epicutaneous and / or intralymphatic immunotherapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

nasal symptom score during the pollen season

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intralymphatic
total12week, 2 JAU 0.02ml/w x 3 times

Interventions/Control_2

epicutaneous
total4week, 2000 JAU 0.2ml/w x 4 times

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Japanese cedar pollinosis

Key exclusion criteria

asthma
under immunotherapy

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kawata Ryo

Organization

Osaka Medical College

Division name

Otorhinolaryngology

Zip code


Address

2-7 Daigaku-cho Takatsuki City Osaka

TEL

072-683-1221

Email

oto034@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Terada Tetsuya

Organization

Osaka Medical College

Division name

Otorhinolaryngology

Zip code


Address

2-7 Daigaku-cho Takatsuki City Osaka

TEL

072-683-1221

Homepage URL


Email

oto056@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Otorhinolaryngology

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding 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



Other administrative information

Date of disclosure of the study information

2014 Year 10 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

Preinitiation

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 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

2014 Year 09 Month 29 Day

Last modified on

2014 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017766


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name