UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003950
Receipt No. R000004757
Scientific Title sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial
Date of disclosure of the study information 2010/07/27
Last modified on 2013/02/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial
Acronym SLIT for Japanese cedar pollinosis
Scientific Title sublingual immunotherapy for Japanese cedar pollinosis: multicenter trial
Scientific Title:Acronym SLIT for Japanese cedar pollinosis
Region
Japan

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

Objectives
Narrative objectives1 evaluate the efficacy and safety of sublingual immunothterapy for Japanese cedar pollinosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes nasal symptoms score (diary)
Key secondary outcomes

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 administraion standerdised Jaanese cedar extract sublingually for 2minute and then spit the extract
Interventions/Control_2 administraion placebo sublingually for 2minute and then spit
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient with allergic rhinitis, who have specific IgE RAST (cedar pollen) score 2 in the past 2years.
2) Patient who have nasal obstruction, and typical allergic rhinitis symptoms for at least 2 years.
3) Written informed consent is required.
Key exclusion criteria 1) Patients with disease which make objective evaluation difficult.
* infection disease
* nonallergic rhinitis
* medicamentosa
2) Anti-allergy drug treatment within two weeks of study entry.
3) Patients who have received immunotherapy.
4) Allergic Rhinitis patients who underwent laser surgery and operation within 6 months.
5) Uncontrolled asthma patients
6) Patients who have the hypersensitivity to study drugs
7) Infectious diseases and mycosis, with no effective therapeutic drug.
8) Pregnant or lactating women and women with possibility of pregnancy.
9) Patients who were judged to be unsuitable for patient enrollment by their doctor.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Gotoh
Organization Nippon Medical School
Division name Otorhinolarygology
Zip code
Address 1-1-5 sendagi bunkyo-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nippon Medical School
Division name Otorhinolaryngology
Zip code
Address
TEL 03-3822-2131
Homepage URL
Email

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization MHLW(Japan)
Organization
Division
Category of Funding Organization
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 07 Month 27 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
2003 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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 07 Month 26 Day
Last modified on
2013 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.