UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005296
Receipt number R000006300
Scientific Title A comparative study of contentment for two H1-blocker treatment for an allergy to cedar pollen.
Date of disclosure of the study information 2011/03/23
Last modified on 2013/03/23 11:03:45

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Basic information

Public title

A comparative study of contentment for two H1-blocker treatment for an allergy to cedar pollen.

Acronym

Comparative study of contentment for H1-blocker

Scientific Title

A comparative study of contentment for two H1-blocker treatment for an allergy to cedar pollen.

Scientific Title:Acronym

Comparative study of contentment for H1-blocker

Region

Japan


Condition

Condition

an allergy to cedar pollen.

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To know the efficacy of the manner which an explanation of drug specific features for two different H1-blockers followed by a prescription of preferable one on patient's contentment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The contentment for an H1-blocker which patient prefers.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

treatment by olopatadine hydrochloride

Interventions/Control_2

treatment by fexofenadine hydrochloride

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

patient's choice

Key exclusion criteria

utilizing any other anti-allergic agent

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Bunya Kuze

Organization

Gifu graduate school of medicine

Division name

Department of Otolaryngology

Zip code


Address

Yanagi-do 1-1, Gifu, Gifu Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Bunya Kuze

Organization

Gifu graduate school of medicine

Division name

Department of Otolaryngology

Zip code


Address

Yanagi-do 1-1, Gifu, Gifu Japan

TEL


Homepage URL


Email

kuze-b@umin.ac.jp


Sponsor or person

Institute

Gifu graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

Gifu graduate school of medicine

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

2011 Year 03 Month 23 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

2011 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2011 Year 05 Month 31 Day

Date of closure to data entry

2011 Year 05 Month 31 Day

Date trial data considered complete

2011 Year 05 Month 31 Day

Date analysis concluded

2012 Year 07 Month 02 Day


Other

Other related information



Management information

Registered date

2011 Year 03 Month 23 Day

Last modified on

2013 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name