UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013007
Receipt number R000015180
Scientific Title Clinical trial of botulinum toxin type A therapy in patients with Japanese cedar pollinosis 2014
Date of disclosure of the study information 2014/02/10
Last modified on 2017/10/03 19:40:28

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Basic information

Public title

Clinical trial of botulinum toxin type A therapy in patients with Japanese cedar pollinosis 2014

Acronym

Effect of Botulinum Toxin Type A Therapy in Patients with Jananese cedar polloniosis(E-Boat study 4)

Scientific Title

Clinical trial of botulinum toxin type A therapy in patients with Japanese cedar pollinosis 2014

Scientific Title:Acronym

Effect of Botulinum Toxin Type A Therapy in Patients with Jananese cedar polloniosis(E-Boat study 4)

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigae 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, Numeric Rating Scale

Key secondary outcomes

Adverse events
Medication Score


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

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One-point-six ml (40U) of botulinum toxin type A soaked cotton sponge is inserted into each nostril and placed on nasa mucosa for 15 to 20min, then removed. anti-histamine tablet and/or eye drops can be used as backup drugs.

Interventions/Control_2

One-point-six ml saline soaked cotton sponge is inserted into each nostril and placed on nasa mucosa for 15 to 20min, then removed. anti-histamine tablet and/or eye drops can be used as backup 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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

a history of Japnese cedar pollinosis in each year and CAP-RAST ageinst Japanese cedar pollen >=2

Key exclusion criteria

1)pregnacy
2)during breast feeding
3)history of heart disease
4)history of neuro-muscular disease
5)history of nasal surgery
6)prominent deviation of the nasal septum

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Kamijo

Organization

Saitama Medical University

Division name

Otorhinolaryngology, Allergy Center

Zip code


Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan

TEL

049-276-1253

Email

atkamijo@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name A

Organization

Saitama Medical University

Division name

Otorhinolaryngology

Zip code


Address

38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan

TEL

049-276-1253

Homepage URL


Email

atkamijo@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Dept Otorhinolarngology and Allergy Center, Saitama Medical University

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

2014 Year 02 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 01 Month 26 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 15 Day

Last follow-up date

2014 Year 05 Month 31 Day

Date of closure to data entry

2015 Year 07 Month 31 Day

Date trial data considered complete

2015 Year 07 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 29 Day

Last modified on

2017 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name