UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014510 |
|---|---|
| Receipt number | 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 10:21:27 |
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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
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
ken-suzu@fujita-hu.ac.jp
Sponsor or person
Institute
Banbuntane Hotokukai Hospital
Department of Otolaryngology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016876
