UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004748 |
|---|---|
| Receipt number | R000005653 |
| Scientific Title | Randomized examination of comparison for the effectiveness and the convenience between the external ear spray and a liquid dropper to otitis externa and otitis media. |
| Date of disclosure of the study information | 2011/01/04 |
| Last modified on | 2011/08/19 17:45:52 |
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Basic information
Public title
Randomized examination of comparison for the effectiveness and the convenience between the external ear spray and a liquid dropper to otitis externa and otitis media.
Acronym
A new method of drug delivery to otitis externa and otitis media.
Scientific Title
Randomized examination of comparison for the effectiveness and the convenience between the external ear spray and a liquid dropper to otitis externa and otitis media.
Scientific Title:Acronym
A new method of drug delivery to otitis externa and otitis media.
Region
| Japan |
Condition
Condition
otitis externa
otitis media
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, the possibility of an external ear spray is examined as a method of effectively and conveniently administering drug solution to otitis externa and otitis media.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Beginning of the treatment and two weeks later, the patient fills in the VAS scale of the ear symptom and the docter evaluates the ear.
Key secondary outcomes
Two weeks after beginning of the treatment,the patients describes the feeling on the questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Patients of otitis externa use betamethasone for two weeks by the ear spray.(twice a day, 5to8 pushes per time)
Interventions/Control_2
Patients of otitis externa use betamethasone for two weeks by the liquid dropper.(twice a day,6to10drops per time)
Interventions/Control_3
Patients of otitis externa use ofloxacin for two weeks by the ear spray.(twice a day, 5to8 pushes per time)
Interventions/Control_4
Patients of otitis externa use ofloxacin for two weeks by the liquid dropper.(twice a day,6to10drops per time)
Interventions/Control_5
Patients of otitis media use betamethasone for two weeks by the ear spray.(twice a day, 5to8 pushes per time)
Interventions/Control_6
Patients of otitis media use betamethasone for two weeks by the liquid dropper.(twice a day,6to10drops per time)
Interventions/Control_7
Patients of otitis media use ofloxacin for two weeks by the ear spray.(twice a day, 5to8 pushes per times)
Interventions/Control_8
Patients of otitis media use ofloxacin for two weeks by the liquid dropper.(twice a day,6to10drops per time)
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of otitis externa and otitis media with ear symptoms
Key exclusion criteria
1,Patients of otitis media with cholesteatoma
2,Patients of ear injury
3,Patients with allergy to ofloxacin
4,Patients with resistance to antibiotic
5,Patients who were rejected by the doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu |
Organization
Saitama Medical University
Division name
Depart
Zip code
Address
350-0495Morohongo 38,Moroyama-machi,Iruma-gun,Saitama,JAPAN
TEL
049-276-1253
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Shibasaki |
Organization
Saitama Medical University
Division name
Department of Otolaryngology and Neuro-otology
Zip code
Address
350-0495Morohongo 38,Moroyama-machi,Iruma-gun,Saitama,JAPAN
TEL
049-276-1253
Homepage URL
oshiba@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University,Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
TAISEI KAKO
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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 18 | Day |
Last modified on
| 2011 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005653
