UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007565
Receipt No. R000008934
Scientific Title Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis.
Date of disclosure of the study information 2012/04/01
Last modified on 2013/09/23

* 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 Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis.
Acronym effect of oral bepotastine besilate as new treatment for allergic rhinitis.
Scientific Title Active comparator stratified randomization study effect oral bepotastine besilate as new treatment for allergic rhinitis.
Scientific Title:Acronym effect of oral bepotastine besilate as new treatment for allergic rhinitis.
Region
Japan

Condition
Condition seasonal allergic rhinitis
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the dose effect of oral bepotastine besilate and combination of different characteristic antiallergic medicine with regard to the efficacy as early seasonal treatment for seasonal allergic rhinitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Alteration of nasal symptom and ocular
condition of four weeks and eight weeks after treatment
Key secondary outcomes Symptom score (stuffy nose,runny nose, sneezing,eye itchiness and tearing), medication score and QOL Questionaire score(JRQLQ No1).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 10mg as bepotastine besilate twice a day orally for 2-3 weeks.
Interventions/Control_2 Upon clinical symptoms after first medical treatment, switch to bepotastine besilate 10mg twice a day or combination treatment with anti leukotriene drugs.
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients with Japanese cedar or cypress pollinosis
Key exclusion criteria (1) Patient that change of symptom is remarkable after specific immunotherapy is begun.
(2) Patient who should continuously use medicine (steroid drugs,immunosuppressive drugs and others) that influences when effect of drug evaluation.
(3)Severity dyshepatia and dysnephria patient.
(4) Pregnancy, potential pregnancy, and breast-feeding patient.
(5) the others, inappropriate to this study by the judgment of doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato MIwa
Organization Juntendo University
Division name Otorhinolaryngology
Zip code
Address 2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL 81338133111
Email mmiwa@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name masato miwa
Organization Juntendo University
Division name Otorhinolaryngology
Zip code
Address 2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL 81338133111
Homepage URL
Email mmiwa@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization self funding
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 順天堂医院

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
2013 Year 01 Month 01 Day
Date trial data considered complete
2013 Year 01 Month 01 Day
Date analysis concluded
2013 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 23 Day
Last modified on
2013 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.