UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009840
Receipt number R000011530
Scientific Title The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber
Date of disclosure of the study information 2013/01/26
Last modified on 2013/04/26 19:04:16

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Basic information

Public title

The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber

Acronym

TOPIC-J STUDY 3(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)

Scientific Title

The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber

Scientific Title:Acronym

TOPIC-J STUDY 3(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)

Region

Japan


Condition

Condition

Japanese cedar pollinosis in children

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Administered 2 months, Pranlukast dry syrup or placebo in children with Japanese cedar pollinosis,just before the cedar pollen dispersal and nasal symptoms induced by OHIO Chmaber to determine the effectiveness of Pranlukast dry syrup in early intervention of cedar pollinosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Nasal symptoms score

Key secondary outcomes

1)No of sneezing
2)Nasal secretion volume
3)Occurrence time of the first nasal symptoms
4)Consumption of rescue medicine
5)Eosinophil cationic protein


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pranlukast dry syrup are orally administered to 15 subjects at twice daily two months.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.

Interventions/Control_2

Placebo dry syrup are orally administered to 15 subjects at twice daily two months.
Japanese cedar pollen exposure mid-Feb. in OHIO Chamber.

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

10 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Multiple antigen simultaneous test score against Japanese cedar pollen over class 2 in the past.
2)Have experience with cedar pollen exposure in OHIO Chamber in the past,patients with nasal symptoms with nasal congestion.
3)Patients who were judged to be suitable for patients enrollment by doctor in screening visit or medical examination results.
4)Written informed consent is required.

Key exclusion criteria

1)Some patients with mucosal lesion of the nose and eyes.
2)Patients who received steroid injections within 6 months.
3)Subjects with deformity of the nose polyp.
4)Subjects with systemic diseases(asthma or tuberculosis).
5)Patients with past history of anaphylaxis.
6)Patients who have the hypersensitivity to study drug.
7)Patients who have received immunotherapy.
8)Patients who were judged to be unsuitable for patients enrollment by doctor.

Target sample size

30


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 113-8603,Japan

TEL


Email



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

CRC Section ,Clinical Trial Operations Support Dept.

Zip code


Address


TEL


Homepage URL


Email

s-shimizu@trcp.co.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

医療法人社団 信濃会 左門町クリニック


Other administrative information

Date of disclosure of the study information

2013 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

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 27 Day

Last follow-up date

2013 Year 04 Month 10 Day

Date of closure to data entry


Date trial data considered complete

2013 Year 04 Month 10 Day

Date analysis concluded

2013 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2013 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011530


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name