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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004999
Receipt No. R000005785
Scientific Title Investigation about the influence that prescription of the different latter period second generation antihistamine gives the satisfaction of the cedar pollinosis patient.
Date of disclosure of the study information 2011/02/02
Last modified on 2012/06/26

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Basic information
Public title Investigation about the influence that prescription of the different latter period second generation antihistamine gives the satisfaction of the cedar pollinosis patient.
Acronym An efficacy competitive study of the antihistamine.
Scientific Title Investigation about the influence that prescription of the different latter period second generation antihistamine gives the satisfaction of the cedar pollinosis patient.
Scientific Title:Acronym An efficacy competitive study of the antihistamine.
Region
Japan

Condition
Condition Cedar or hinoki pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the different second generation antihistamine with regard to the efficacy and the satisfaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The symptom of a nose and eyes.
Patient questionnaire.
Key secondary outcomes Quality Of Life.
Pollinosis diary.
Side effect.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 olopatadine hydrochloride therapy
Interventions/Control_2 fexofenadine hydrochloride therapy
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
7 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cedar pollinosis confirmed at the site, the following criteria must be met;
(1)7 years old and more than it.
(2)Sex no object.
(3)No objectaccording to a thing of hospitalization / an outpatient.
(4)The patient whom disease severity is more than seriously ill in "Practical Guideline for the Management of Allergic Rhinitis in Japan".
Key exclusion criteria (1)The patient who has comlications of a nose disease of the degree to disturb an effect judgment.
(2)The patient that the symptom change is remarkable.
(3)The patient who must use the drug which has an influence on the effect judgment of the study drug during the study period.
(4)Sever liver/renal disease.
(5)Woman who are pregnant or breast feeding, and woman of childbearing potential.
(6)Patient who was considered ineligible by the investigators.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shiga
Organization Kanazawa Medical University Hospital
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Shiga
Organization Kanazawa Medical University Hospital
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL 076-286-2211
Homepage URL
Email shigah@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University Hospital
Institute
Department

Funding Source
Organization Kanazawa Medical University Hospital
Organization
Division
Category of Funding Organization Self funding
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 02 Month 02 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
2010 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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
2011 Year 02 Month 02 Day
Last modified on
2012 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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