UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014556 |
|---|---|
| Receipt number | 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 09:36:23 |
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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
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
asoda@z3.keio.jp
Public contact
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
asoda@z3.keio.jp
Sponsor or person
Institute
Department of Dentistry and Oral Surgery, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016899
