Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer. - Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer.

ational Cancer Center Hospital0 个研究点目标入组 30 人开始时间: 2022年11月18日最近更新: 2023年10月17日

适应症

试验速览

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•1)Patients diagnosed with diabetic neuropathy. 2)Patients with cervical or lumbar spondylosis causing neuropathic pain. 3)Patients with creatinine clearance (Cockcroft-Gault formula)less than 30 mL/min at enrollment. 4)Women who are pregnant or breast-feeding, who need to continue breast-feeding after starting study drug administration, or who may be pregnant. 5)Patients with a history of hypersensitivity reaction to mirogabalin besilate. 6)Concomitant use of the following drugs: pregabalin, gabapentin, Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine, clomipramine, SNRIs: duloxetine, venlafaxine, milnacipran, Antiepileptic drugs: carbamazepine, sodium valproate, lamotrigine, topiramate, clonazepam, Kampo medicine: goshajinkigan Other: cimetidine, probenecid. 7)Patients who newly added the following drugs or changed the dose (increase or decrease) by 10% or more within 14 days before registration. Opioid analgesics, tramadol, NSAIDs, acetaminophen. 8)Patients who are complicated by psychosis or psychiatric symptoms that interfere with daily life and are judged to be difficult to participate in the study. 9)In addition, those who are judged to be inappropriate as research subjects by the principal investigator or co-investigator.

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