UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012211 |
|---|---|
| Receipt number | R000014277 |
| Scientific Title | Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2013/11/04 20:51:20 |
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Basic information
Public title
Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel
Acronym
Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel
Scientific Title
Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel
Scientific Title:Acronym
Investigation of preventive effect with neurotropin for neuropathy due to paclitaxel
Region
| Japan |
Condition
Condition
The patient of gynecologic cancer treated with paclitaxel
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effect of neurotropin for neuropathy due to paclitaxel
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Level of sensory neuropathy
Key secondary outcomes
level of motor neuropathy
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
neurotropin
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
The patients necessary for chemotherapy with paclitaxel doe to gynecologic cancer (vertical cancer, corpus cancer, ovarian cancer, tubal cancer and peritoneal cancer)
Key exclusion criteria
The patient with neuropathy due to other reason such as diabetes merits
THe patient with neuropathy due to progressive original disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Irahara |
Organization
The University of Tokushima
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7177
irahara@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Nishimura |
Organization
The University of Tokushima
Division name
Department of Obsterics and Gynecology
Zip code
Address
3-18-15 Kuramoto-cho Tokushima
TEL
088-633-7177
Homepage URL
nishimura.masato@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, The University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, The University of Tokushima
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
| 2013 | Year | 11 | Month | 04 | Day |
Last modified on
| 2013 | 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=R000014277
