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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005647
Receipt No. 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

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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
Email 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
Email ynanya-tky@umin.ac.jp

Sponsor
Institute Tokyo University, Dep. of Hematology and Oncology
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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