UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001809 |
|---|---|
| Receipt number | R000002152 |
| Scientific Title | To evaluate the efficacy and safety of KP-496NS for patients with perennial allergic rhinitis |
| Date of disclosure of the study information | 2009/04/01 |
| Last modified on | 2009/10/02 09:21:58 |
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Basic information
Public title
To evaluate the efficacy and safety of KP-496NS for patients with perennial allergic rhinitis
Acronym
An exploratory study of KP-496NS (Phase II)
Scientific Title
To evaluate the efficacy and safety of KP-496NS for patients with perennial allergic rhinitis
Scientific Title:Acronym
An exploratory study of KP-496NS (Phase II)
Region
| Japan |
Condition
Condition
Perennial allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of KP-496NS for patients with perennial allergic rhinitis and the dose-response relationship.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Nasal symptom score, rhinoscopic findings, side effects
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo
Interventions/Control_2
KP-496NS 0.1%
Interventions/Control_3
KP-496NS 0.3%
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients having moderate or severe perennial allergic rhinitis and nasal songestion
(2) Patients giving a written informed consent
(3) Patients having tested positive for both of the following allergic tests
1) Specific IgE radio-allergo-sorbent-test (RAST)
2) Nasal eosinophil count
Key exclusion criteria
(1) Patients having diseases that could interfere with assessment of treatment
(2) Patients are/having recieved treatment for diseases that could interfere with assessment of treatment
(3) Patients with bleeding tendency
(4) Patients with problems in safety
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunkichi Baba |
Organization
Graduated school of Medicine, Nagoya City University, emeritus professor
Division name
Department of Otorhinolaryngology
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, Japan, 467-8601
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Division name
Clinical Development Department
Zip code
Address
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo 113-8650, Japan
TEL
Homepage URL
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 04 | Month | 01 | 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
| 2009 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 28 | Day |
Last modified on
| 2009 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002152
