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.
Mirogabalin has been approved in China for the treatment of DPNP. Although there is evidence of the safety and efficacy of mirogabalin, there is a lack of real-world evidence on its safety and effectiveness to inform decision-making among a more diverse patient population in real-world clinical practice, such as patients with moderate or severe renal impairment; patients with more complications, comorbidities, and treatments; and patients with different severity of pain. This study aims to collect safety and effectiveness data to guide physicians in the clinical use of mirogabalin for the treatment of patients with DPNP in the real-world clinical practice setting.
Study Type
OBSERVATIONAL
Enrollment
721
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.
Proportion of participants with any treatment related adverse events (TRAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Baseline to Week 14
Time-to-onset of somnolence, dizziness, weight gain, and peripheral edema
For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated.
Time frame: Baseline to Week 14
Symptom duration of somnolence, dizziness, weight gain, and peripheral edema
For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated.
Time frame: Baseline to Week 14
Proportion of participants with TEAEs, serious TEAEs, TRAEs leading to study treatment discontinuation
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Baseline to Week 14
Change from baseline in VAS pain
The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.
Time frame: Week 14
Proportion of participants achieving 30% and 50% pain relief (reduction in VAS score compared to baseline)
The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.
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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
...and 33 more locations
Time frame: Baseline to Week 14
Time to achieve 30% pain relief or 50% pain relief (reduction in VAS score compared to baseline)
The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.
Time frame: Baseline to Week 14
Change from baseline in Douleur Neuropathique 4 questions (DN4) score
DN4 will be assessed by the investigator after ICF signed and prior to the first administration of mirogabalin as baseline, when participants return to the clinical site during treatment period of mirogabalin, and at the end of mirogabalin treatment. Each "yes" answer is assigned 1 point, and a total score is calculated. A score of 4 or higher indicates a higher likelihood of neuropathic pain (eg. worse clinical outcome), while a score below 3 suggests it is less likely (eg. better clinical outcome).
Time frame: Week 14
Patient Global Impression of Change (PGIC)
Participants will provide a self-assessment using the 7-point scale via ePRO at the end of mirogabalin treatment: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Lower PGIC scores indicate better clinical outcome.
Time frame: Week 14
Change from baseline in EuroQol 5-Dimension 5-level (EQ-5D-5L)
The self-administered EQ-5D-5L includes the EQ-5D and the EQ VAS. EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3-moderate problems, 4=severe problems and 5=extreme problems. The patient is asked to indicate his/her health state in each of the five dimensions, resulting in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Lower 5-digit numbers indicates better clinical outcome (ie, health state). The EQ VAS records the patient's self-rated health on a vertical VAS where the endpoints are labelled '100 - The best health you can imagine' and '0 - The worst health you can imagine'. Higher EQ VAS scores indicate better clinical outcome/health.
Time frame: Week 14