UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002494 |
|---|---|
| Receipt number | R000003060 |
| Scientific Title | The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity : a prospective randomized study |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2009/09/14 22:04:18 |
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Basic information
Public title
The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity : a prospective randomized study
Acronym
The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity : a prospective randomized study
Scientific Title
The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity : a prospective randomized study
Scientific Title:Acronym
The effects of Gosha-jinki-gan on oxaliplatin-related neurotoxicity : a prospective randomized study
Region
| Japan |
Condition
Condition
unresectable colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of Gosha-jinki-gan for neurotoxicity of L-OHP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurotoxicities were evaluated every course according to DEB-NTC (Neurotoxicity Criteria of DEBIOPHARM) and NCI-CTCAE Ver.3.0 using self-check sheet.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
none
Interventions/Control_2
Gosha-jinki-gan
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
Male and Female
Key inclusion criteria
Unresectable colon cancer
Key exclusion criteria
guideline
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
The University of Tokushima
Division name
Digestive Surgery
Zip code
Address
31815 kuramoto tokusima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokushima
Division name
Digestive Surgery
Zip code
Address
TEL
Homepage URL
yoshik@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokusima
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2009 | Year | 10 | 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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 14 | Day |
Last modified on
| 2009 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003060
