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Completed NCT06812117

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)

Conditions: Diabetic Peripheral Neuropathic Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 721
Sponsor: Daiichi Sankyo

Location: China-Japan friendship hospital Beijing

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06812117). StuddyBuddy aggregates publicly available trial information.