UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003132 |
|---|---|
| Receipt number | 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 09:49:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Department of Otorhinolaryngology , Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003796
