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 |
* 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
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
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
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
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
