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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002721
Receipt No. 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

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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
Email

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
Email y-saito@tokyorinsho-cro.co.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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