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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010687
Receipt No. R000012491
Scientific Title A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Date of disclosure of the study information 2013/05/25
Last modified on 2013/11/10

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Basic information
Public title A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Acronym A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Scientific Title A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Scientific Title:Acronym A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Region
Japan

Condition
Condition Japanese cedar Pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A clnical study to assess inhibitory effect of bepotastine besilate OD tablet to compare with fexofenadine hydrochloride and pseudoephedrine hydrochloride combination tablet in patients with cedar pollinosis in the OHIO Chamber.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective symptoms
Key secondary outcomes Nasal secretion volume
Number of sneezing
Exercise-based treatment programs

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Term I: placebo
Interventions/Control_2 Term II: test drug or reference drug
Interventions/Control_3 Term III: reference drug or test drug
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
65 years-old >
Gender Male and Female
Key inclusion criteria CAPRAST score against Japanese cedar pollen from 2 to 6 within the last 2 years.
Patient whom the nose symptom that was apparent to the cedar pollen scattering period past 2 years developed in.
Key exclusion criteria 1)Patients with mucosal lesion of the nose and eyes.
2)Patients with severe or requiring treatment needed Allergic Rhinitis.
3)Patients who received steroid injections within 6 months.
4)Patients with respiratory disease such as asthma.
5)Patients with past history of anaphylaxis.
6)Patients who have anaphylaxis with these drugs.
7)Patients with pregnancy, delivery or lactation.
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimihiro Okubo
Organization Nippon Medical School
Division name Department of Otorhinolaryngology and Head/Neck Surgery
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email ent-kimi@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Shimizu
Organization Tokyo Reserch Center of Clinical Pharmacology co.,ltd.
Division name Customer Relations Dept.
Zip code
Address 20, Samon-cho, Shinjyuku-ku, Tokyo
TEL 03-5366-3454
Homepage URL
Email s-shimizu@trcp.co.jp

Sponsor
Institute Samoncho Clinic
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma
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
2013 Year 05 Month 25 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
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 10 Day
Last modified on
2013 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012491

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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