{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["13(4)"],"submitter":["Guo X"],"funding":["Daiichi Sankyo Co., Ltd."],"pubmed_abstract":["<h4>Introduction</h4>There is no approved effective drug for diabetic peripheral neuropathic pain (DPNP) in China. Gabapentinoids including mirogabalin have shown promise, although data in Chinese patients are scarce.<h4>Methods</h4>This phase 3, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of mirogabalin for treating DPNP in China. Mirogabalin was administered at 5 mg twice daily for the first week and uptitrated to 15 mg twice daily for a total duration of 14 weeks. The primary efficacy endpoint was the change from baseline in weekly average daily pain score (ADPS) at week 14; secondary endpoints included the ADPS responder rate, Short-Form McGill Pain Questionnaire visual analogue scale score, patient global impression of change (P"],"journal":["Pain and therapy"],"pagination":["937-952"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11255142"],"repository":["biostudies-literature"],"pubmed_title":["A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain."],"pmcid":["PMC11255142"],"pubmed_authors":["Sun L","Li Y","Kikumori K","Guo X","Zhang Y","Song B","Wasaki Y","Hang L","Murayama E","Yu Y","Baba M"],"additional_accession":[]},"is_claimable":false,"name":"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain.","description":"<h4>Introduction</h4>There is no approved effective drug for diabetic peripheral neuropathic pain (DPNP) in China. Gabapentinoids including mirogabalin have shown promise, although data in Chinese patients are scarce.<h4>Methods</h4>This phase 3, multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of mirogabalin for treating DPNP in China. Mirogabalin was administered at 5 mg twice daily for the first week and uptitrated to 15 mg twice daily for a total duration of 14 weeks. The primary efficacy endpoint was the change from baseline in weekly average daily pain score (ADPS) at week 14; secondary endpoints included the ADPS responder rate, Short-Form McGill Pain Questionnaire visual analogue scale score, patient global impression of change (P","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Aug","modification":"2026-06-02T22:54:43.894Z","creation":"2025-04-06T17:10:52.933Z"},"accession":"S-EPMC11255142","cross_references":{"pubmed":["38896199"],"doi":["10.1007/s40122-024-00617-2"]}}