Unique ID issued by UMIN | UMIN000041467 |
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Receipt number | R000046790 |
Scientific Title | Effect of Mirogabalin in patients with Chemotherapy-induced peripheral neuropathy : A Multicenter, Phase 2 Trial |
Date of disclosure of the study information | 2020/08/19 |
Last modified on | 2022/11/10 01:44:53 |
Effect of Mirogabalin in patients with Chemotherapy-induced peripheral neuropathy : A Multicenter, Phase 2 Trial
M-CIPN
Effect of Mirogabalin in patients with Chemotherapy-induced peripheral neuropathy : A Multicenter, Phase 2 Trial
M-CIPN
Japan |
Chemotherapy induced peripheraly neuropathy
Medicine in general |
Malignancy
NO
We conduct to evaluate the efficacy and safety of mirogabalin fot the chemotherapy induced peripheraly neuropathy patients.
Efficacy
Phase II
NRS
CTCAE, FACT/GOS-Nt
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
We prescribe mirogabalin for up to 12 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with pathologically consistent with multiple myeloma, malignant lymphoma, gastric cancer, colorectal cancer, sarcoma or pancreatic cancer.
2. Patiesnts with administered Bordezomib, vincristine, platinum preparations (cisplatin, oxaliplatin), or microtubule inhibitor preparations (paclitaxel, paclitaxel, Nabupaclitaxel, docetaxel, eribulin).
3. CTCTE ver5.0 Grade 2 or more, NRS 4 points to NRS 8 points/10 points CIPN.
4. over 20 years old.
5. Informed consent had been obtained.
1. Other than multiple myeloma, malignant lymphoma, gastric cancer, colon cancer, sarcoma and pancreatic cancer.
2. CIPN of Grade 1 or lower, or NRS 3 points or lower or NRS 9 points or higher in CTCTE ver5.0.
3. CIPN thought to be caused by other than bordezomib, vincristine, platinum preparations (cisplatin, oxaliplatin), and microtubule inhibitor preparations (paclitaxel, nabupaclitaxel, docetaxel, eribulin).
4. ECOG-PS4 or poor general condition.
5. Patients who are using the following drugs in combination: antidepressants, SSRI/SNRI, antiepileptic drugs, opioids, goshajinkigan, Vitamin B12 preparations.
6. Diagnosed as severe heart disease or lung disease.
7. Diagnosed as poor renal function with creatinine clearance of less than 60 mL/min.
8. Pregnant women, lactating women or those who may be pregnant.
9. The patients who were ineligible.
100
1st name | MAKOTO |
Middle name | |
Last name | YOSHIDA |
Sapporo Medical University
Department of Medical Oncology
060-8543
291, S1W16, Chuo-Ku, Sapporo, Hokkaido, Japan
011-611-2111
yoshimako10@sapmed.ac.jp
1st name | MAKOTO |
Middle name | |
Last name | YOSHIDA |
Sapporo Medical University
Department of Medical Oncology
060-8543
291, S1W16, Chuo-Ku, Sapporo, Hokkaido, Japan
011-611-2111
yoshimako10@sapmed.ac.jp
Sapporo Medical University
Sapporo Medical University
Other
Sapporo Medical University
291, S1W16, Chuo-Ku, Sapporo, Hokkaido, Japan
011-611-2111
yoshimako10@sapmed.ac.jp
NO
2020 | Year | 08 | Month | 19 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 02 | Month | 03 | Day |
2020 | Year | 04 | Month | 09 | Day |
2020 | Year | 04 | Month | 09 | Day |
2025 | Year | 09 | Month | 30 | Day |
2020 | Year | 08 | Month | 19 | Day |
2022 | Year | 11 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046790
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