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 sites30 target enrollmentNovember 18, 2022

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: esophageal cancer, gastric cancer, small bowel cancer, colon cancer, pancreatic cancer
Sponsor: ational Cancer Center Hospital
Enrollment: 30
Status: Not yet recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 18, 2022

End Date

January 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.