UMIN ID: UMIN000000672
Registered date:05/04/2007
Prediction of drug adverse event through gene expression analysis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | embedded dens molaris |
| Date of first enrollment | 2007/01/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cefcapene Pivoxil Hydrochloride Hydrate 100mg po administration for three times |
Outcome(s)
| Primary Outcome | correlation and differences of gene expression between results from basic experiments in vitro and ones in human |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 60years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | JICHI MEDICAL UNIVERSITY |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | HEALTH AND LABOUR SCIENCES RESEARCH GRNTS |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 0285-58-7550 |
| Affiliation | Jichi Medical University SCHOOL AFFAIRS SECTION |
| scientific contact | |
| Name | Akio Fujimura, MD, PhD |
| Address | Shimotsuke-si, Tochigi-ken Japan |
| Telephone | |
| Affiliation | Jichi Medical University Clinical Pharmacology |