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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003132
Receipt No. R000003796
Scientific Title Investigation of patient satisfaction to Second-generation antihistamines in the treatment of Japanese cedar and cypress family pollinosis.
Date of disclosure of the study information 2010/02/03
Last modified on 2016/08/29

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Basic information
Public title Investigation of patient satisfaction to Second-generation antihistamines in the treatment of Japanese cedar and cypress family pollinosis.
Acronym Investigation of patient satisfaction in pollinosis to antihistamines.
Scientific Title Investigation of patient satisfaction to Second-generation antihistamines in the treatment of Japanese cedar and cypress family pollinosis.
Scientific Title:Acronym Investigation of patient satisfaction in pollinosis to antihistamines.
Region
Japan

Condition
Condition Japanese cedar and cypress family pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The distribution medicine is administered to two groups "Medicine of which the feature is height in the effect" and "Medicine that assumes few of drowsiness to be a feature" by the patient's hope for the pollinosis patient, and the influence and the patient satisfaction are investigated on the effect and QOL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Transitions of nasal symptom and ocular condition of two weeks after beginning of the treatment from first medical examination
Key secondary outcomes Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1).
Satisfaction rating to treatment.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 From the first medical examination, administer 5 mg as olopatadine hydrochloride
twice a day orally in the morning and at bedtime , at least two weeks.
Interventions/Control_2 From the first medical examination, administer 60 mg as fexofenadine hydrochloride twice a day orally , at least two weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) It is pollinosis caused by Japanese cedar or cypress pollen and a final diagnosis is a done patient.
(2) Patient judged that severity of symptoms when beginning to investigate is more than slight illness based on risk stratification of "Practical Guideline for the Management of Allergic Rhinitis in Japan(2009)"
(3) Written informed consent is required.
Key exclusion criteria (1) with nasal diseases such as nasal polyps, hypertrophic rhinitis, acute chronic rhinitis, or deviated septum which cause a barrier to evaluate nasal symptoms.
(2) Patient that change of symptom is remarkable after specific immunotherapy is begun.
(3) Patient who should continuously use medicine (antiallergic drugs, antihistamine drugs, anticholinergic drugs, a complex of histamine/ Gamma-globulin preparations, vasoconstrictor drugs and antihypertensive drugs) that influences when effect of drug evaluation.
(5) Pregnancy, potential pregnancy, and breast-feeding patient.
(6) the others, inappropriate to this study by the judgment of doctor.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eriko Hoshi
Organization Shiga University of Medical Science
Division name Department of Otorhinolaryngology
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga, JAPAN
TEL 077-541-2261
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shiga University of Medical Science
Division name Department of Otorhinolaryngology
Zip code
Address
TEL 077-541-2261
Homepage URL
Email

Sponsor
Institute Department of Otorhinolaryngology , Shiga University of Medical Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2010 Year 02 Month 03 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2016 Year 08 Month 29 Day
Date trial data considered complete
2016 Year 08 Month 29 Day
Date analysis concluded
2016 Year 08 Month 29 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 02 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003796

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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