UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006987 |
|---|---|
| Receipt number | R000008243 |
| Scientific Title | A prospective study to evaluate the efficacy and safety of pregabalin for triweekly abraxane-induced peripheral neuralgia |
| Date of disclosure of the study information | 2011/12/29 |
| Last modified on | 2011/12/29 11:46:49 |
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Basic information
Public title
A prospective study to evaluate the efficacy and safety of pregabalin for triweekly abraxane-induced peripheral neuralgia
Acronym
Pregabalin for abraxane-induced peripheral neuralgia
Scientific Title
A prospective study to evaluate the efficacy and safety of pregabalin for triweekly abraxane-induced peripheral neuralgia
Scientific Title:Acronym
Pregabalin for abraxane-induced peripheral neuralgia
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of pregabalin for abraxane-induced peripheral neuralgia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients which PNQ score improved after administration of pregabalin
Key secondary outcomes
The rate of patients which SF-MPQ score improved after administration of pregabalin
The rate of patients which VAS score improved by more than 50% after administration of pregabalin
The rate of patients which NCI-CTCAE grade improved after administration of pregabalin
The number of courses in which peripheral neuropathy occurred
The site of onset of peripheral neuropathy
Safety
The number of treatment courses
Time to improvement in patients who developed grade 3 peripheral 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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pregabalin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who received abraxane for breast cancer and suffer from more than grade 2 peripheral neuralgia
2. Patients with no peripheral neuropathy caused by diabetes and other disease
3. 20 years old or more
4. Possible oral intake
5. Estimated life expectancy of at least 6 months
6. Signed informed consent
Key exclusion criteria
1. Contraindication to abraxane and pregabalin
2. Creatinine clearance less than 30mL/min
3. With previous history of pregabalin
administration
4. With unstable dosage of antidepressant drugs at 3 weeks of registration
5. With serious drug allergy
6. With severe complications
7. Pregnant or nursing women
8. With peripheral neuropathy caused by other drugs
9. Determination as contraindication by doctors
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tsurutani |
Organization
Kinki University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Kinki University Faculty of Medicine
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 | 12 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | 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
| 2011 | Year | 12 | Month | 29 | Day |
Last modified on
| 2011 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008243
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
