UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004979 |
|---|---|
| Receipt number | R000005733 |
| Scientific Title | Efficacy and safety of Garenoxacin for the prevention in the patients with hematological malignancies after chemotherapy |
| Date of disclosure of the study information | 2011/01/31 |
| Last modified on | 2016/11/04 21:57:18 |
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Basic information
Public title
Efficacy and safety of Garenoxacin for the prevention in the patients with hematological malignancies after chemotherapy
Acronym
Garenoxacin for the prevention in hematological malignancies
Scientific Title
Efficacy and safety of Garenoxacin for the prevention in the patients with hematological malignancies after chemotherapy
Scientific Title:Acronym
Garenoxacin for the prevention in hematological malignancies
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the effect and safety of Garenoxacin for prevention in the patients with hematological malignancies after chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Frequencies of feblile neutropenia
Key secondary outcomes
Frequencies of adverse events
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
| Medicine |
Interventions/Control_1
Garenoxacin for prevention
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Hematological malignancies
2)Neutropenia is expected to continue for one week or more
3)Written informed consent was obtained from each patient before enrollment in the study
4)Patient who was judged that prophylaxis is necessary
Key exclusion criteria
1)GRNX is obviously ineffective to the pathogen.
2)Patients with a history of allergy/severe adverse effect to quinolone antibacterial agents or garenoxacin
3)Allergic diathesis
4)Pregnancy/lactation
5)Age of 15 years or younger
6)Patient was received systemic antibacterial therapy within 14 days
7)Patients who are regarded as inadequate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
Homepage URL
htsuru@gifu-u.aco.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2011 | Year | 01 | Month | 31 | 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
| 2010 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | 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
| 2011 | Year | 01 | Month | 30 | Day |
Last modified on
| 2016 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005733
