Oct. 02, 2021 |
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Nov. 28, 2022 |
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jRCT2051210097 |
A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy |
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Exploratory Study of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy |
Kondou Kazuoki |
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Mitsubishi Tanabe Pharma Corporation |
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1-1-1, Marunouchi Chiyoda-ku, Tokyo |
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+81-3-5960-9608 |
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cti-inq-ml@ml.mt-pharma.co.jp |
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Information Desk Clinical Trials |
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Mitsubishi Tanabe Pharma Corporation |
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1-1-1, Marunouchi Chiyoda-ku, Tokyo |
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+81-3-5960-9608 |
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cti-inq-ml@ml.mt-pharma.co.jp |
Complete |
Nov. 01, 2021 |
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Nov. 16, 2021 | ||
144 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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(1) Patients with written consent |
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(1) Patients with pain, disease, or skin condition that, in the opinion of the investigator (or sub-investigator), would influence the evaluation of painful diabetic peripheral neuropathy. |
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20age old over | ||
No limit | ||
Both |
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Painful Diabetic Peripheral Neuropathy |
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MT-8554 Group: MT-8554 will be started from a low dose, and gradually increase the dose in order while confirming its tolerability. Then, continue treatment at the maximum dose that is confirmed to be tolerable. MT-8554 will be administered for a total of 12 weeks. |
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Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period |
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(1) Change from baseline in weekly mean 24-hour average NRS score at each assessment point |
Mitsubishi Tanabe Pharma Corporation |
Omi Medical Center and Omi Fureai Hospital Institutional Review Board | |
1660 Yabase, Kusatsu, Shiga | |
+81-77-563-8866 |
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chiken@kusatsu-gh.or.jp | |
Approval | |
Yes |
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Plan Description: When requested by a qualified researcher in the field of science or medicine, Mitsubishi Tanabe Pharma Corporation (MTPC) will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.mt-pharma.co.jp/e/develop/protocol/ |
NCT05123196 | |
ClinicalTrials.gov |
none |