UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001657 |
|---|---|
| Receipt number | R000001998 |
| Scientific Title | A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis |
| Date of disclosure of the study information | 2009/01/26 |
| Last modified on | 2009/04/08 10:36:21 |
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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
Acronym
Effect of Botrinum Toxin type A therapy in Patients with Japanese cedar pollinosis
(E-BOAT study)
Scientific Title
A double-blind placebo-controlled clinical trial of botulinum toxin type A injection therapy in patients with Japanese cedar pollinosis
Scientific Title:Acronym
Effect of Botrinum Toxin type A therapy in Patients with Japanese cedar pollinosis
(E-BOAT study)
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 Japanese cedar pollinosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Symptom score, symptom-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
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Botulinum toxin A (20 U, 0.2ml) is injected into each nasal cavity just before the beginning of pollen scattering. Ten mg of loratadine and/ or mometazone nasal spray can be used as a backup drug.
Interventions/Control_2
Saline (0.2ml) is injected into each nasal cavity just before the beginning of pollen scattering. Ten mg of loratadine and/ or mometasone nasal spray can be used as a backup drug.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)a history of Japanese cedar pollinosis
2)CAP-RAST against Japanese cedar pollen ≥2
Key exclusion criteria
1)pregnancy or possibility of pregnancy
2)history of heart disease
3)history of glaucoma
4)history of prostate hypertrophy
5)history of neuro-muscular disease
6)history of stroke
7)accompanying acute rhinitis or sinusitis
8)use of any anti-allergy drugs at the beginning of the study
9)history of nose/sinus surgery
10)prominent deviation of the nasal septum
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Masuyama |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1110 Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-6769
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kamijo |
Organization
University of Yamanashi
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1110 Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-6769
Homepage URL
botoxchiken@live.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery
Faculty of Medicine, University of Yamanash
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NONE
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
| 2009 | Year | 01 | Month | 26 | 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
| 2008 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 26 | Day |
Last modified on
| 2009 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001998
