UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038742
Receipt No. R000044039
Scientific Title The efficacy and safety of mirogabalin for tha chemotherapy induced peripheral neuropathy patients in Gemcitabine+nab-Paclitaxel therapy
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy and safety of mirogabalin for tha chemotherapy induced peripheral neuropathy patients in Gemcitabine+nab-Paclitaxel therapy
Acronym The efficacy and safety of mirogabalin for tha CIPN patients in GnP therapy
Scientific Title The efficacy and safety of mirogabalin for tha chemotherapy induced peripheral neuropathy patients in Gemcitabine+nab-Paclitaxel therapy
Scientific Title:Acronym The efficacy and safety of mirogabalin for tha CIPN patients in GnP therapy
Region
Japan

Condition
Condition Chemotherapy induced peripheraly neuropathy
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Gemcitabine+nab-Paclitaxel therapy is useful for pancreatic cancer patients, but chemotherapy induced peripheraly neuropathy often occurred, leading to decrease the QOL in those patients. We conduct to evaluate the efficacy and safety of mirogabalin fot the chemotherapy induced peripheraly neuropathy patients in Gemcitabine+nab-Paclitaxel therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient-Reported Outcome CTCAE
Key secondary outcomes EORTC-CIPN20,NRS

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 1 over 20 years old
2 The patients who were treated by GnP therapy.
3 The patients who had CIPN and taken mirogabalin at least 2 weeks.
4 Informed consent had been obtained.
Key exclusion criteria 1 The patients who could not write
questionnaire.
2 The patients who were ineligible.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Isayama
Organization Juntendo university
Division name Department of Gastroenterology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email h-isayama@juntendo.ac.jp

Public contact
Name of contact person
1st name Yusuke
Middle name TAKASAKI
Last name Takasaki
Organization Juntendo university
Division name Department of Gastroenterology
Zip code 113-8421
Address Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ytakasa@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization self funding
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 Juntendo university
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-3814-5672
Email kenkyu5858@juntendo.ac.jp

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
2019 Year 12 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
2019 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information not paticular

Management information
Registered date
2019 Year 11 Month 30 Day
Last modified on
2019 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.