UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003859 |
|---|---|
| Receipt number | R000004645 |
| Scientific Title | The assessment of the appropriate duration of early intervention for Japanese cedar pollinosis by a leukotriene-receptor antagonist |
| Date of disclosure of the study information | 2010/07/02 |
| Last modified on | 2010/07/02 12:53:45 |
* 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
The assessment of the appropriate duration of early intervention for Japanese cedar pollinosis by a leukotriene-receptor antagonist
Acronym
The assessment of the appropriate duration of early intervention for Japanese cedar pollinosis by a leukotriene-receptor antagonist
Scientific Title
The assessment of the appropriate duration of early intervention for Japanese cedar pollinosis by a leukotriene-receptor antagonist
Scientific Title:Acronym
The assessment of the appropriate duration of early intervention for Japanese cedar pollinosis by a leukotriene-receptor antagonist
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the appropriate duration of early intervention for Japanese cedar pollinosis patients with montelukast.
We compared 4 treatment regimens. The 4 treatment regimens were montelukast treatment for 1day, 3days,7 days and placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TNSS(total nasal symptom score)
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After an observation period of 14 days, a placebo is administered orally for 6 days.
Montelukast is administered orally for a day after placebo administration.
Patients are exposed to cedar pollen after montelukast therapy by using the OHIO Chamber.
Interventions/Control_2
After an observation period of 14 days, a placebo is administered orally for 4 days.
Montelukast is administered orally for 3 days after placebo administration.
Patients are exposed to cedar pollen after montelukast therapy by using the OHIO Chamber.
Interventions/Control_3
After an observation period of 14 days, a placebo is administered orally for 7 days.
Patients are exposed to cedar pollen after montelukast therapy by using the OHIO Chamber.
Interventions/Control_4
After an observation period of 14 days, a placebo is administered orally for 7 days.
Patients are exposed to cedar pollen after montelukast therapy by using the OHIO Chamber
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
112
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiro Okubo |
Organization
Nippon Medical School
Division name
Department of Otolaryngology
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Samoncho Clinic
Division name
Pharmaceutical Dept.
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Samoncho Clinic
Institute
Department
Personal name
Funding Source
Organization
Public Health Research 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
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 | 02 | 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 | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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 | 02 | Day |
Last modified on
| 2010 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004645
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
