Phase
Condition
Pain (Pediatric)
Pain
Treatment
No Drug
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must meet all the following criteria to be eligible for this study.
Age ≥ 18 years at the time of informed consent form (ICF) signed.
Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy).
Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed.
Patients who are mirogabalin naïve prior to ICF signed and planned to initiate mirogabalin treatment.
Patients who are able to give signed ICF for study participation and willing to provide access to previous and future medical information.
Patients who meet any of the following criteria will be excluded from this study.
Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP.
Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness.
Patients who received pregabalin, gabapentin, crisugabalin, or any other DPNP analgesic medications* within 7 days prior to ICF signed.
*Other DPNP analgesic medication includes TCAs (amitriptyline, nortriptyline), SNRIs (duloxetine, venlafaxine), antiepileptics (carbamazepine), opioids (tapentadol, tramadol).
Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline.
Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin.
Patients with simultaneous participation in any interventional clinical study.
Female patients at the status of pregnancy, potential pregnancy, or breast feeding.
Patients who have been judged by the investigator to be unsuitable to participate in the study.
Study Design
Study Description
Connect with a study center
Beijing Pinggu Hospital
Beijing, 101200
ChinaSite Not Available
China-Japan friendship hospital
Beijing, 100013
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, 100730
ChinaSite Not Available
Xuanwu Hospital Capital Medical University
Beijing, 100053
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, 410008
ChinaSite Not Available
Chengdu First People's Hospital
Chengdu, 610041
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, 610072
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, 610041
ChinaSite Not Available
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
ChinaSite Not Available
The First People's Hospital Of Foshan
Fo Shan Shi, 528041
ChinaSite Not Available
Shunde Hospital of southern Medical University
Foshan, 528300
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510000
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangzhou, 510515
ChinaSite Not Available
The First Affiliated Hospital of Jinan University
Guangzhou, 510632
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou, 310025
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science & Technology
Henan, 471622
ChinaSite Not Available
The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008
ChinaSite Not Available
Pingxiang People's Hospital
Pingxiang, 337005
ChinaSite Not Available
Qingdao Municipal Hospital
Qingdao, 266001
ChinaSite Not Available
Huashan Hospital Fudan University
Shanghai, 200040
ChinaSite Not Available
Shanghai Tenth People's Hospital
Shanghai, 200080
ChinaSite Not Available
ZhongShan Hospital Fudan University
Shanghai, 20032
ChinaActive - Recruiting
Shenzhen Nanshan People's Hospital
Shenzhen, 518020
ChinaSite Not Available
First Hospital of Shanxi Medical University
Taiyuan, 030001
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin, 300211
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430014
ChinaSite Not Available
Wuxi People's Hospital
Wuxi, 214028
ChinaSite Not Available
Yibin Second People's Hospital
Yibin, 644603
ChinaSite Not Available

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