UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006421 |
|---|---|
| Receipt number | R000007621 |
| Scientific Title | Protective efficacy of pregabalin to peripheral neuropathy induced by oxaliplatin or paclitaxel |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2015/03/30 11:46:59 |
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Basic information
Public title
Protective efficacy of pregabalin to peripheral neuropathy induced by oxaliplatin or paclitaxel
Acronym
Protective efficacy of pregabalin to chemotherapy-induced neuropathy
Scientific Title
Protective efficacy of pregabalin to peripheral neuropathy induced by oxaliplatin or paclitaxel
Scientific Title:Acronym
Protective efficacy of pregabalin to chemotherapy-induced neuropathy
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Hematology and clinical oncology | Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify possible protective effect of pregabalin on oxaliplatin- or paclitaxel-induced neurophathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of peripheral neuropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Prebgabalin
Interventions/Control_2
Placebo
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Cancer patients who will be treated with oxaliplatin- or paclitaxel-based chemotherapy
2. Patients who can take pregabalin
3. Patients with written informed consent
Key exclusion criteria
1. Patients with a history of oxaliplatin or paclitaxel chemotherapy
2. Patients with peripheral neuropathy
3. Patients treated with pregabalin
4. Patients with allergy history for pregabalin
5. Patients with cleatinine clearance of 30 mL/min or less
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohji Naora |
Organization
Shimane University Hospital
Division name
Department of Pharmacy
Zip code
Address
89-1, Enya-cho, Izumo, Japan
TEL
0853-23-2111
knaora@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohji Naora |
Organization
Shimane University Hospital
Division name
Department of Pharmacy
Zip code
Address
89-1, Enya-cho, Izumo, Japan
TEL
0853-23-2111
Homepage URL
knaora@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
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
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007621
