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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013812
Receipt No. 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

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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
Email 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
Email atkamijo@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016120

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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