Multicenter Collaborative Prospective Exploratory Study on Diabetic Peripheral Neuropathic Pain (Multicenter Collaborative Prospective Exploratory Study on Diabetic Peripheral Neuropathic Pain)

未提供0 个研究点目标入组 3,000 人开始时间: 2025年3月31日最近更新: 2025年5月28日

试验速览

暂无简介。

•<Baseline survey (primary enrollment)>
•Outpatients with a diagnosis of type 2 diabetes mellitus at the time of informed consent
•Patients aged 18 years or older at the time of informed consent
•Patients who gave written consent based on the patient's own free will
•<Mirogabalin intervention study (secondary enrollment)>
•Patients diagnosed with DPNP at the baseline survey*1 and having a pain NRS*3 of 1 or higher based on subjective symptoms*2 of DPN at the time of secondary entry.
•1: Diagnosis of DPN is made using the "Simplified Diagnostic Criteria for Diabetic Polyneuropathy" in Table 1-a of Chapter 10 of the 2024 Diabetes Treatment Guidelines, and based on this diagnosis, DPNP is diagnosed.
•2: Subjective symptoms based on DPN at the time of secondary entry are defined as 1) bilateral, 2) numbness, pain, and paresthesia of the toes and soles (but not only paresthesia), and 3) no symptoms of the upper extremities alone. 2) "Numbness," "pain," and "paresthesia" of the toe tip and sole are read based on "Subjective symptoms probably based on diabetic neuropathy" (Appendix 3) from the neuropathy questionnaire collected from the study subjects.
•3:Pain NRS:An index that evaluates the intensity of pain on an 11-point scale from 0 to 10.

•<Baseline survey (primary enrollment)>
•Patients who are judged by the investigator to be inappropriate as research subjects
•<Mirogabalin intervention study (secondary enrollment)>
•Patients who meet any of the following criteria at secondary entry will be excluded.
•Patients who do not wish to participate in the mirogabalin intervention study
•Patients who are considered to be hospitalized
•Subjects with severe pain due to diseases other than DPNP and considered difficult to assess
•Patients taking research drugs and prohibited concomitant drugs within 28 days before secondary enrollment
•Individuals with creatinine clearance (CLcr) below 30 mL/min*
•Patients with concomitant severe liver, kidney or heart disease
•Patients who are participating in or are scheduled to participate in other intervention studies
•Patients who are pregnant or possibly pregnant, breastfeeding, or attempting pregnancy within 6 months after obtaining informed consent
•Other patients whose investigators judged them inappropriate for participating in the mirogabalin intervention study
•: CLcr use the most recent serum-creatinine level in the 12 months prior to secondary enrollment

Change in pain NRS from baseline

时间窗: 12 weeks after initiation of mirogabalin

Change in pain NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin

PGIC Distribution
Change in EQ-5D-5L at Weeks 4 and 12 after initiation of mirogabalin(Weeks 4 and 12 after initiation of mirogabalin)
Change in sleep-disordered NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin(12 weeks after initiation of mirogabalin)
Changes in the International-Standardized Physical Activity Questionnaire (IPAQ) at 4 and 12 weeks after initiation of mirogabalin(4 and 12 weeks after initiation of mirogabalin)

发起方

未提供