UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005647 |
|---|---|
| Receipt number | R000006674 |
| Scientific Title | A prospectve study to evaluate the efficacy of pregabalin for chemotherapy-induced peripheral nueralgia |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2017/05/30 12:01:14 |
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Basic information
Public title
A prospectve study to evaluate the efficacy of pregabalin for chemotherapy-induced peripheral nueralgia
Acronym
Pregabaalin for chemotherapy-induced peripheral nueralgia
Scientific Title
A prospectve study to evaluate the efficacy of pregabalin for chemotherapy-induced peripheral nueralgia
Scientific Title:Acronym
Pregabaalin for chemotherapy-induced peripheral nueralgia
Region
| Japan |
Condition
Condition
Patients who suffers from peripehral neuralgia which is induced by antineaoplastic agents that were adeministered for therapy of hematological malignancies
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The object of this study is to evaluate the efficacy fo pregabalin by prospectively describing the effficacy of this agent who received pregabalin for chemotherapy-induced peripheral neuralgia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of patients whose PNQ grade (neuralgia score) improved at the 4th week after administration of pregabalin
Key secondary outcomes
1. The rate of patients whose PNQ grade (neuralgia score) improved at the first, second, and third week after administration of pregabalin
2. The rate of patients whose McGill Pain Questionnaire score (which depicts qualitative properties of neuralgia) changed at the first, second, and third, and 4th week after administration of pregabalin.
3. The rate of patients whose VAS score improved at the first, second, and third week after administration of pregabalin
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who received chemotherapeutic agents for hematological malignancies and suffer from sensory neural disturbances which are assumed to be induced by the chemotherapies.
Key exclusion criteria
1. decreased renal function (creatinine clearance equal to 60mL/min or less)
2. ocular disturbances including vision abnoramlity
3. underlying diabetes mellitus or postherpetic neuralgia
4. with previous history of pregabalin
administration
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhito Nannya |
Organization
Tokyo University Hospital
Division name
Dep. of Hematology and Oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku
TEL
+81-3-3815-5411
ynanya-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Nannya/Ryo Nasu |
Organization
Tokyo University Hospital
Division name
Dep. of Hematology and Oncology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku
TEL
0338155411
Homepage URL
ynanya-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo University, Dep. of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
Research funds, Tokyo University
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 | 06 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
Doctors fill in the case report form which includes sex, age, underlying hematological diseases, history of therapy against the diease, and dose of pregabarin administered.
Patients fill in the symptoms report form before and four times weekly after the administaration of pregabarin. Patients report the quantity and characters of neuralgia.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006674
| 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 |
