UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013812 |
|---|---|
| Receipt number | R000016120 |
| Scientific Title | Efficacy and safety of sitafloxacin (STFX) in tonsillar abcess; prospective study in outpatient setting. |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2019/03/29 11:20:39 |
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Basic information
Public title
Efficacy and safety of sitafloxacin (STFX) in tonsillar abcess; prospective study in outpatient setting.
Acronym
Efficacy and safety of sitafloxacin in tonsillar abcess.
Scientific Title
Efficacy and safety of sitafloxacin (STFX) in tonsillar abcess; prospective study in outpatient setting.
Scientific Title:Acronym
Efficacy and safety of sitafloxacin in tonsillar abcess.
Region
| Japan |
Condition
Condition
peritonsillar abcess
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of sitafloxacin in peritonsiller abcess.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptom, objective findings, CRP, WBC
Key secondary outcomes
adverse events
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
200mg/day of sitafloxacin for 1-2weeks
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed peritonsillar abcess.
Key exclusion criteria
Patients who need hospitalization
Allergy for sitafloxacin
pregnant or probable pregnant
renal dysfunction (Ccr<50)
airway stenosis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kamijo |
Organization
Saitama Medical University
Division name
Otorhinolaryngology, Allergy Center
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1253
atkamijo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kamijo |
Organization
Saitama Medical University
Division name
Otorhinolaryngology
Zip code
Address
38 Morohongo, Moroyama-machi, Irum-gun, Saitama, Japan
TEL
049-276-1253
Homepage URL
atkamijo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Dept Otorhinolaryngology, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
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 | 04 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016120
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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