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Clinical Trials in China / NCT06812117
Active, not recruiting Observational

A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)

NCT06812117 · tracked via the Priya Life Science China tracker
Sponsor
Daiichi Sankyo
Phase
Observational
Started
2025-01-24
Last updated
2026-03-30

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

No Drug

No Drug: This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on mirogabalin will be enrolled in this study.

Study summary

This study will evaluate the safety and effectiveness of mirogabalin in adult patients with diabetic peripheral neuropathic pain (DPNP) in real-world clinical practice setting in China.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients must meet all the following criteria to be eligible for this study. 1. Age ≥ 18 years at the time of informed consent form (ICF) signed. 2. Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy). 3. Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed. 4. Patients who are mirogabalin naïve prior to ICF signed and planned to initiate mirogabalin treatment. 5. 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. 1. Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP. 2. Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness. 3. 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). 4. Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline. 5. Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin. 6. Patients with simultaneous participation in any interventional clinical study. 7. Female patients at the status of pregnancy, potential pregnancy, or breast feeding. 8. Patients who have been judged by the investigator to be unsuitable to participate in the study.

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
China-Japan friendship hospital Beijing China
Xuanwu Hospital Capital Medical University Beijing China
Peking Union Medical College Hospital Beijing China
Beijing Pinggu Hospital Beijing China
Xiangya Hospital of Central South University Changsha China
Chengdu First People's Hospital Chengdu China
West China Hospital of Sichuan University Chengdu China
Sichuan Provincial People's Hospital Chengdu China
Chengdu Fifth People's Hospital Chengdu China
The Second Affiliated Hospital of Chongqing Medical University Chongqing China
The First People's Hospital Of Foshan Foshan China
Shunde Hospital of southern Medical University Foshan China
Fujian Medical University Union Hospital Fuzhou China
Guangdong Provincial People's Hospital Guangzhou China
The First Affiliated Hospital, Sun Yat-sen University Guangzhou China
Nanfang Hospital of Southern Medical University Guangzhou China
The First Affiliated Hospital of Jinan University Guangzhou China
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou China
Zhejiang Provincial People's Hospital Hangzhou China
The First Affiliated Hospital of Henan University of Science & Technology Henan China
The First People's Hospital Of Yunnan Kunming China
The Affiliated Hospital of Nanjing University Medical School Nanjing China
The Fourth Affiliated Hospital of Nanjing Medical University Nanjing China
Nanyang First People's Hospital Nanyang China
The First Affiliated Hospital of Nanyang Medical College Nanyang China
Pingxiang People's Hospital Pingxiang China
Qingdao Municipal Hospital Qingdao China
The Affiliated Hospital of Qingdao University Qingdao China
Renji Hospital, Shanghai Jiaotong University School Of Medicine Shanghai China
Huadong Hospital Shanghai China
Huashan Hospital Fudan University Shanghai China
Shanghai Tenth People's Hospital Shanghai China
ZhongShan Hospital Fudan University Shanghai China
Shenzhen Nanshan People's Hospital Shenzhen China
First Hospital of Shanxi Medical University Taiyuan China
Taizhou People's Hospital Taizhou China
The Second Hospital of Tianjin Medical University Tianjin China
The First Affiliated Hospital of Wenzhou Medical University Wenzhou China
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China
Wuhan Central Hospital Wuhan China

+ 3 more sites — see the full list on the official registry below.

More Daiichi Sankyo trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06812117 on ClinicalTrials.gov ↗ ← All trials in China