UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004585
Receipt number R000005459
Scientific Title Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis
Date of disclosure of the study information 2010/11/28
Last modified on 2011/05/25 12:24:54

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Basic information

Public title

Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis

Acronym

PRAN study

Scientific Title

Effect of Pranlukast on allergic symptoms and nasal Nitric oxide levels in patients with Japanese cedar pollinosis

Scientific Title:Acronym

PRAN study

Region

Japan


Condition

Condition

Patients with Japanese cedar pollinosis

Classification by specialty

Clinical immunology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the usefulness of measuring nasal nitric oxide (NO) levels as a disease marker in patients with Japanese cedar pollinosis, and to see the effect of pranlukast on allergic symptoms and nasal NO levels in those patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

nasal NO levels, symptoms score, volume of nasal secretion, number of seezing

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

pranlukast

Interventions/Control_2

placebo

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

19 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with Japanese cedar pollinosis

Key exclusion criteria

Patients with respiratory diseases such as asthma.
Patients with past history of anaphylaxis.
Patients with hypersensitivity to pranlukast.
Pregnant woman or breast-feeding woman.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshi Katsunuma

Organization

The Jikei University School of Medicine

Division name

Deapartment of Pediatrics, Jikei Daisan Hospital

Zip code


Address

4-11-1, Izumihoncho, Komae City, Tokyo

TEL

03-3480-1151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshio Katsunuma

Organization

PRAN study group

Division name

PRAN study office

Zip code


Address

Deapartment of Pediatrics, Jikei Daisan Hospital

TEL


Homepage URL


Email



Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University Research Fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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 11 Month 28 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

2010 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 18 Day

Last modified on

2011 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name