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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003065
Receipt No. R000003719
Scientific Title A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2010
Date of disclosure of the study information 2010/01/25
Last modified on 2017/10/03

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Basic information
Public title A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2010
Acronym Effect of Botrinum Toxin Type A Therapy in Patients with Japanese cedar pollinosis (E-BOAT study 2)
Scientific Title A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis 2010
Scientific Title:Acronym Effect of Botrinum Toxin Type A Therapy in Patients with Japanese cedar pollinosis (E-BOAT study 2)
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy and safety of botulinum toxin type A in patients with Japnese cedar pollinosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Symptom score, Medication score, QOL estimation, rhinomanometry
Key secondary outcomes adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One ml (20U) of botulinum toxin type A is injecjected into each inferior turbinate just before the beggining of pollen scattering. Loratadine (10mg)and/or Betamethasone/d-Chlorpheniramine Maleate can be used as a backup drug.
Interventions/Control_2 One ml (10U) of botulinum toxin type A is injecjected into each inferior turbinate just before the beggining of pollen scattering. Loratadine (10mg) and/or Betamethasone/d-Chlorpheniramine Maleate can be used as a backup drug.
Interventions/Control_3 One ml saline is injecjected into each inferior turbinate just before the beggining of pollen scattering. Loratadine (10m) and/or Betamethasone/d-Chlorpheniramine Maleate can be used as a backup 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
18 years-old <=
Age-upper limit
59 years-old >
Gender Male and Female
Key inclusion criteria 1) a history of Japanese cedar pollinosis
2) CAP-RAST aginst Jananese cedar pollen >=2
Key exclusion criteria 1) pregnancy or possibility of pregnancy
2) history of heart desease
3) history of glaucoma
4) history of prostate hypertrophy
5) history of neuro-muscular desiases
6) history of stroke
7) accampanying acute rhinitis or sinusitis
8) use of any anti-allergy drugs at the beginning of the study
10) prominent deviation of the nasal septum
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Masuyama
Organization University of Yamanashi
Division name Department of Otorhinolaryngoloty, Head and Neck Surgery
Zip code
Address 1110 Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-6769
Email akamijo@yamaanshi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Kamijo
Organization University of Yamanashi
Division name Department of Otorhinolaryngoloty, Head and Neck Surgery
Zip code
Address 1110 Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-6769
Homepage URL
Email akamijyo@yamanashi.ac.jp

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery
Faculty of Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization NONE
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 01 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
2009 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 20 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003719

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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