UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041845 |
|---|---|
| Receipt number | R000047769 |
| Scientific Title | Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2020/09/18 19:31:01 |
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Basic information
Public title
Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Acronym
Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Scientific Title
Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Scientific Title:Acronym
Effect of Fexofenadine/Pseudoephedrine combination tablet on Nasal Obstruction in Patients with Allergic Rhinitis
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we estimated the efficacy of fexofenadine/pseudoephedrine on nasal obstruction in patients with perennial allergic rhinitis versus fexofenadine using objective methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nasal airflow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
measure nasal airflow for 8 hours at 30-minute intervals after taking a single agent: fexofenadine/pseudoephedrine combination tablet
Interventions/Control_2
measure nasal airflow for 8 hours at 30-minute intervals after taking a single agent:fexofenadine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) with a history of allergic rhinitis
(2) with nasal obstruction
(3) house dust mite allergy based on skin reactions or serum allergen-specific IgE antibody measurements.
Key exclusion criteria
(1) upper respiratory tract infection
(2) allergen-specific immunotherapy
(3) pregnancy, or lactation
(4) patients with hypertension, severe asthma
(5)a history of known hypersensitivity, allergic reactions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Takeuchi |
Organization
Tottori University
Division name
Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code
683-8503
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
oto3175@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Otolaryngology, Head and Neck Surgery, Department of Medicine of Sensory and Motor Organ
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago
TEL
0859-38-6627
Homepage URL
yosuken@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculity of Medicine,Tottori university
Address
36-1 Nishi-cho, Yonago
Tel
0859-38-7108
me-kenkyu@ml.adm.tottori-u.ac.jp
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
| 2020 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Main results already published
Date of protocol fixation
| 2013 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047769
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
