UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038742
Receipt number 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 2022/09/03 23:56:16

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

submitting

Publication of results

Unpublished


Result

URL related to results and publications

submitting

Number of participants that the trial has enrolled

25

Results

Increased numbness and tingling severity(1.84 vs 1.76; P=0.63)and interference(1.42 vs 1.44; P=0.80)were not seen in any of the 25 enrolled patients.

Results date posted

2022 Year 06 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Background: Gemcitabine/nab-paclitaxel therapy (GnP) is widely used to treat pancreatic cancer (PC), but chemotherapy-induced peripheral neuropathy (CIPN) is common. Mirogabalin is a novel drug for treating peripheral neuropathy. We investigated the effects of mirogabalin on CIPN due to GnP.

Participant flow

Retrospective study

Adverse events

somnolence, dizziness, edema

Outcome measures

PRO-CACAE, EORTC-QLQ-CIPN20, NRS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 11 Month 22 Day

Date of IRB

2019 Year 12 Month 26 Day

Anticipated trial start date

2019 Year 12 Month 26 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

2022 Year 09 Month 03 Day



Link to view the page

Value
https://center6.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