UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004999 |
|---|---|
| Receipt number | 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 14:32:09 |
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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
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
shigah@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005785
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
