UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002721 |
|---|---|
| Receipt number | R000003314 |
| Scientific Title | Placebo-controlled trial to compare the inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms, using a nasal provocation test with orchard grass pollen antigen disc in orchard grass pollinosis. |
| Date of disclosure of the study information | 2009/11/06 |
| Last modified on | 2009/12/21 17:38:07 |
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Basic information
Public title
Placebo-controlled trial to compare the inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms, using a nasal provocation test with orchard grass pollen antigen disc in orchard grass pollinosis.
Acronym
Inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms by nasal provocation test with orchard grass pollen antigen disc.
Scientific Title
Placebo-controlled trial to compare the inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms, using a nasal provocation test with orchard grass pollen antigen disc in orchard grass pollinosis.
Scientific Title:Acronym
Inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms by nasal provocation test with orchard grass pollen antigen disc.
Region
| Japan |
Condition
Condition
Orchard grass pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the inhibitory effects of epinastine hydrochloride for orchard grass pollinosis on nasal symptoms (onset times of nasal symptoms from provocation, duration of drug effects) using a randomized, double-blinded, single-dose, placebo-controlled crossover clinical study by comparing with matched placebo.
The measurements are onset of time from the provocation and duration of the drug effects of epinastine hydrochloride, compared with those of matched placebo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of epinastine hydrochloride on nasal symptoms for nasal provocation test by orchard grass pollen antigen disc
Key secondary outcomes
Nasal finding score by rhinoscopy
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Epinastine hydrochloride tablet 20 mg is orally administered to subjects as single dose 60 minutes after the first nasal provocation with orchard grass pollen antigen disc.
Interventions/Control_2
Matched placebo of epinastine hydrochloride tablet is orally administered 60 minutes after the first nasal provocation with orchard grass pollen antigen disc.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CAP-RAST score against orchard grass pollen over class 3 or greater within the last 3 years, and positive nasal provocation reaction to the orchard grass antigen disc on screening.
Key exclusion criteria
Subjects;
1) with a history of hypersensitivity to the components of epinastine hydrochloride tablet,
2) used steroids within one month of the start day of the clinical study,
3) within one week of the start day of the clinical study, used drugs that may affect the results of the clinical study (antihistamines, antiallergic drugs, vasoconstrictors),
4) without nasal response to the provocation by a history of laser therapy and/or nasal procedure for undergoing desensitization to orchard grass pollinosis,
5) with nasal diseases that affect the assessment of the nasal provocation reaction, such as acute chronic rhinitis, nasal polyps, hypertrophic rhinitis, deviated septum or sinusitis,
6) reactive to multiple antigens including pollens (cedar, mugwort) other than orchard grass, and had worsening of nasal symptoms when the nasal provocation test was conducted during the pollen dispersal season,
7) pregnancy, potential pregnancy, and breast-feeding mothers.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiro Okubo |
Organization
Nippon Medical School
Division name
Department of Otorhinolaryngology and Head/Neck Surgery
Zip code
Address
1-5 Sendagi 1 chome, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
+81-3-3822-2131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Saito |
Organization
Tokyo Clinical CRO Co, Ltd
Division name
Clinical Development II
Zip code
Address
20 Samon-cho, Shinjuku-ku, Tokyo 160-0017 Japan
TEL
+81-3-5366-1720
Homepage URL
y-saito@tokyorinsho-cro.co.jp
Sponsor or person
Institute
Nippon Medical School
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
左門町クリニック/Samoncho Clinic（東京都/Tokyo）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 06 | 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 | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 06 | Day |
Last modified on
| 2009 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003314
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