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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025948
Receipt No. 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

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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
Email 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
Email no-mori@mebix.co.jp

Sponsor
Institute Ito ENT Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029827

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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