UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008554 |
|---|---|
| Receipt number | R000010055 |
| Scientific Title | The Pharmacokinetical Study of the milk in travenous cyclophosphamide therapy. |
| Date of disclosure of the study information | 2012/07/27 |
| Last modified on | 2013/01/29 10:31:58 |
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Basic information
Public title
The Pharmacokinetical Study of the milk in travenous cyclophosphamide therapy.
Acronym
The Pharmacokinetical Study of the milk in travenous cyclophosphamide therapy.
Scientific Title
The Pharmacokinetical Study of the milk in travenous cyclophosphamide therapy.
Scientific Title:Acronym
The Pharmacokinetical Study of the milk in travenous cyclophosphamide therapy.
Region
| Japan |
Condition
Condition
SLE (systemic lupus erythematosus)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examine the drug concentration of milk in travenous cyclophosphamide therapy.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration measurement and assessment of the breast-fed child's safety.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
measuring instrument
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
| 41 | years-old | <= |
Age-upper limit
| 41 | years-old | >= |
Gender
Female
Key inclusion criteria
SLE
travenous cyclophosphsmide therapy
breast feeding
Key exclusion criteria
nothing
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Hirahara |
Organization
Yokohama City University School of Medicine
Division name
obstetrics and gynecology
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University School of Medicine
Division name
obstetrics and gynecology
Zip code
Address
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
not yet
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 07 | Month | 27 | 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
| 2012 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 27 | Day |
Last modified on
| 2013 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010055
