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
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
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
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
