UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014258 |
|---|---|
| Receipt number | R000016579 |
| Scientific Title | Examination of tissue penetration of garenoxacin (GRNX) for peritonsillar abscess |
| Date of disclosure of the study information | 2014/06/13 |
| Last modified on | 2018/03/01 11:50:53 |
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Basic information
Public title
Examination of tissue penetration of garenoxacin (GRNX) for peritonsillar abscess
Acronym
Examination of tissue penetration of garenoxacin (GRNX) for peritonsillar abscess
Scientific Title
Examination of tissue penetration of garenoxacin (GRNX) for peritonsillar abscess
Scientific Title:Acronym
Examination of tissue penetration of garenoxacin (GRNX) for peritonsillar abscess
Region
| Japan |
Condition
Condition
peritonsillar abscess
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the transition of the pus to palatine tonsil tissue and serum in peritonsillar abscess patients GRNX400mg oral administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target patients over 20 years old who immediately abscess tonsillectomy for the treatment of peritonsillar abscess. In patients who ingest the GRNX, tonsil tissue taken at the time of surgery, pus, each serum, to measure the concentration of GRNX. Target number of cases to 20 cases.
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
Period until March 31, 2015 from a clinical study approval date.
For patients over the age of 20, garenoxacin performing oral administration of 400mg.
Evaluated is scheduled for 20 cases.
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
For the treatment of peritonsillar abscess, orally ingestible the garenoxacin (GRNX), patients over 20 years old that underwent abscess tonsillectomy.
Key exclusion criteria
Case can not be obtained consent to participate in this study excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Kurono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima, JAPAN
TEL
099-275-5410
entjm@m.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Miyashita |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima, JAPAN
TEL
099-275-5410
Homepage URL
entjm@m.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Head and Neck Surgery
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co., Ltd.
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 13 | 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
| 2013 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016579
| 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 |
