UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000672 |
|---|---|
| Receipt number | R000000808 |
| Scientific Title | Prediction of drug adverse event through gene expression analysis |
| Date of disclosure of the study information | 2007/04/05 |
| Last modified on | 2012/04/09 15:42:02 |
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Basic information
Public title
Prediction of drug adverse event through gene expression analysis
Acronym
Prediction of drug adverse event through gene expression analysis
Scientific Title
Prediction of drug adverse event through gene expression analysis
Scientific Title:Acronym
Prediction of drug adverse event through gene expression analysis
Region
| Japan |
Condition
Condition
embedded dens molaris
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to confirm gene expression related to drug adverse events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation and differences of gene expression between results from basic experiments in vitro and ones in human
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
Cefcapene Pivoxil Hydrochloride Hydrate 100mg po administration for three times
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
those who are planned to receive exodontics of one of embedded third dens molaris
Key exclusion criteria
renal dysfunction (Creatinin equal or greater than 2.0 mg/dl)
liver dysfunction (ALT, AST, T-bil, LDH or ALP are more than two times greater than upper limit of normal range)
confirmed or clinically suspected myocardial infarction and/or congestive heart failure
prescribed medicines for diabetes mellitus and/or hypertension
pasthistory for hypersensitivities and/or allargic reactions against Cefcapene Pivoxil Hydrochloride Hydrate or ingredients of Flomox(R)
Past history of hypersensitivities for Cephalosporins
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Fujimura, MD, PhD |
Organization
Jichi Medical University
Division name
Clinical Pharmacology
Zip code
Address
Shimotsuke-si, Tochigi-ken
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University
Division name
SCHOOL AFFAIRS SECTION
Zip code
Address
TEL
0285-58-7550
Homepage URL
Sponsor or person
Institute
JICHI MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
HEALTH AND LABOUR SCIENCES RESEARCH GRNTS
Organization
Division
Category of Funding 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
| 2007 | Year | 04 | Month | 05 | 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
| 2006 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 05 | Day |
Last modified on
| 2012 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000808
