UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025948 |
|---|---|
| Receipt number | R000029827 |
| Scientific Title | Clinical effectiveness of 2nd generation antihistamine (Observational Study) |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2018/01/11 14:01:25 |
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Basic information
Public title
Clinical effectiveness of 2nd generation antihistamine
(Observational Study)
Acronym
Clinical effectiveness of 2nd generation antihistamine
(Observational Study)
Scientific Title
Clinical effectiveness of 2nd generation antihistamine
(Observational Study)
Scientific Title:Acronym
Clinical effectiveness of 2nd generation antihistamine
(Observational Study)
Region
| Japan |
Condition
Condition
Seasonal allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the clinical effectiveness of switching to tricyclic from non-tricyclic structural antihistamic drug in insufficiently patients with seasonal allergic rhinitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) from week 0 (Visit 1) to week 4 (Visit 3)
Key secondary outcomes
(1) Symptoms, QOL
- T4NSS sub-score: score at each visit
- Score of JRQLQ No.1 items I & II
- Overall condition: face scale of JRQLQ No.1 items III
(2) Treatment satisfaction
- Treatment satisfaction percentage in questionnaire
Other evaluation
(3) Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria at the visit1:
(1) Patients who have been diagnosed over 2 years ago with allergic rhinitis to Japanese cedar or other pollens
(2) Patients aged 20 or older and younger than 80 years
(3) Patients with a T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) of 8 or more remaining after at least 2 weeks of taking non-tricyclic structural second generation antihistamic drug, where there is a plan to switch to tricyclic structural antihistamic drug
(4) Patients who can provide written consent for participation in this study themselves and of their own free will with sufficient understanding after receiving sufficient explanation
(5) Patients without communication problems
Key exclusion criteria
Patients who meet the following conditions (at Visit 1) are not selected as subjects:
(1) Patients who have been treated with allergen immunotherapy
(2) Patients with abnormal nasal cavity morphology such as nasal polyps or deviated nasal septum
(3) Patients with severe liver or kidney dysfunction
(4) Patients who are pregnant, breastfeeding, or desire pregnancy during the study period
(5) In addition, patients who are judged to be inappropriate as subjects by the researcher
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Ito |
Organization
Ito ENT Clinic
Division name
Ito ENT Clinic
Zip code
Address
6-30-26 Chiyoda, Aoi-ku, Shizuoka-shi, Shizuoka
TEL
054-265-1000
itoclinic@rouge.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhide Mori |
Organization
Mebix, Inc.
Division name
Research Promotion Group
Zip code
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-4362-4504
Homepage URL
no-mori@mebix.co.jp
Sponsor or person
Institute
Ito ENT Clinic
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 02 | Month | 01 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
Prospective multicenter observational study
Registration period: 1st of February 2017 to 31st of March 2017
Study period: 1st of February 2017 to 30th of April 2017
Study period: 4 weeks.
Management information
Registered date
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029827
