UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017345 |
|---|---|
| Receipt number | R000020128 |
| Scientific Title | Search of related factors with the hypoglycemia in use of the antibiotic containing pivoxyl group against infants |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2017/03/14 11:34:12 |
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Basic information
Public title
Search of related factors with the hypoglycemia in use of the antibiotic containing pivoxyl group against infants
Acronym
Antibiotic containing pivoxyl group and infants with hypoglycemia
Scientific Title
Search of related factors with the hypoglycemia in use of the antibiotic containing pivoxyl group against infants
Scientific Title:Acronym
Antibiotic containing pivoxyl group and infants with hypoglycemia
Region
| Japan |
Condition
Condition
Hypoglycemia
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The antibiotic containing pivoxyl group may cause hypoglycemia with hyper carnitinemia in long use of it. It is need for monitoring of it at the age from 0 to 5 years-old. This study investigates the transition of the urine and serum concentration of carnine and acyl-carnibitine and search of the useful factor for early prediction of hypoglycemia in use of antibiotic containing pivoxyl group.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The urine and serum concentration of carnitine and acyl-carnitine, plasma glucose level, biochemical laboratory data.
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
| 0 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The infant patient taking the antibiotic containing pivoxyl group
Key exclusion criteria
No
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nariyasu Mano |
Organization
Tohoku university hospital
Division name
Department of pharmaceutical sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7525
mano@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamitsu Maekawa |
Organization
Tohoku university hospital
Division name
Department of pharmaceutical sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7541
Homepage URL
m-maekawa@hosp.tohoku.ac.jp
Sponsor or person
Institute
Department of pharmaceutical sciences, Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of pediatrics, Tohoku university hospital
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
However a simultaneous analytical method for carnnitine metabolites and the antibiotic drug was developed, no samples from patients with adverse effects by antibiotics having pivoxyl group were recruited.
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
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
The blood and urine concentration of carnitine and acyl-carnitine of patient with taking the antibiotic containing pivoxyl group are analyzed by LC/MS/MS and the factors related with adverse effect are searched.
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020128
