UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014556
Receipt No. R000016899
Scientific Title Oral and Maxillofacial tissue penetration of Sitafloxacin following oral administration of single 100 mg dose
Date of disclosure of the study information 2014/07/15
Last modified on 2014/07/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Oral and Maxillofacial tissue penetration of Sitafloxacin following oral administration of single 100 mg dose
Acronym Oral and Maxillofacial penetration of Sitafloxacin
Scientific Title Oral and Maxillofacial tissue penetration of Sitafloxacin following oral administration of single 100 mg dose
Scientific Title:Acronym Oral and Maxillofacial penetration of Sitafloxacin
Region
Japan

Condition
Condition Impacted third molar teeth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exam the transfer of Sitafloxacin into serum, gingiva, dental follicles, and madibular bone following oral administration of a single 100mg dose of Sitafloxacin,and analysis on the efficacy of Sitafloxacin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exam the transfer of Sitafloxacin into serum, gingiva, dental follicles, and madibular bone after 2.0 to 4.5h following oral administration of a single 100mg dose of Sitafloxacin.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The patient who needs to extract the third molar teeth
Key exclusion criteria 1.Patients with allergies to any other antibiotics.
2.Patients who are pregnant or trying to get pregnant, or during the breastfeeding.
3.Patients who has disease that needs medical attention in the emergency, or who has liver,kidney and heart failure.
4.Patients with epilepsy.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Seiji Asoda
Organization School of Medicine, Keio University
Division name Department of Dentistry and Oral Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku,Tokyo
TEL 03-3353-1205
Email asoda@z3.keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Seiji Asoda
Organization School of Medicine, Keio University
Division name Department of Dentistry and Oral Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku,Tokyo
TEL 03-3353-1205
Homepage URL
Email asoda@z3.keio.jp

Sponsor
Institute Department of Dentistry and Oral Surgery, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Department of Dentistry and Oral Surgery, School of Medicine, Keio 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 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Phase 1 trial, Clinical trial activation plan

Management information
Registered date
2014 Year 07 Month 15 Day
Last modified on
2014 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.