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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004748
Receipt No. 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

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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
Email

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
Email oshiba@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University,Department of Otolaryngology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005653

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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