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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014510
Receipt No. R000016876
Scientific Title Pharmacokinetics of the oral antibiotic, faropenem in middle ear tissues.
Date of disclosure of the study information 2014/07/09
Last modified on 2015/07/13

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Basic information
Public title Pharmacokinetics of the oral antibiotic, faropenem in middle ear tissues.
Acronym Distribution of faropenem in middle ear.
Scientific Title Pharmacokinetics of the oral antibiotic, faropenem in middle ear tissues.
Scientific Title:Acronym Distribution of faropenem in middle ear.
Region
Japan

Condition
Condition Chronic otitis media
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pharmacokinetics of the oral antibiotic, faropenem in chronic otitis media.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FRPM
Interventions/Control_2
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) Chronic otitis media patients who are over 20 years old.
2) Patients who need a surgery to remove the middle ear tissues.
3) Patients who signed informed consent prior to participation.
Key exclusion criteria 1) Patients who had been removed the tympanal organs by surgeries.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Suzuki
Organization Banbuntane Hotokukai Hospital
Division name Department of Otolaryngology
Zip code
Address 3-6-10 Otobashi, Nakagawaku
TEL 052-321-8171
Email ken-suzu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Suzuki
Organization Banbuntane Hotokukai Hospital
Division name Department of Otolaryngology
Zip code
Address 3-6-10 Otobashi, Nakagawaku
TEL 052-321-8171
Homepage URL
Email ken-suzu@fujita-hu.ac.jp

Sponsor
Institute Banbuntane Hotokukai Hospital
Department of Otolaryngology
Institute
Department

Funding Source
Organization Maruho Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 09 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
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 09 Day
Last follow-up date
2015 Year 03 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
2014 Year 07 Month 08 Day
Last modified on
2015 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016876

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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