Neuropathic pain (diabetic neuropathy, traumatic neuropathy, post-infection neuropathy) Neuropathic pain
Conditions
Interventions
Sponsors
Suzuki Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic patients with diabetic peripheral neuropathy and patients with neuropathic pain after trauma or infection who are visiting or hospitalized at Fujita Health University Hospital and Sakura General Hospital
Exclusion criteria
Exclusion criteria: 1. Patients who have been treated with mirogabalin 30 mg / day in the past and are judged to be ineffective 2. Patients with hypersensitivity to mirogabalin, pregabalin, or gabapentin 3. Patients with the following abnormalities before participating in the study or by screening test AST / ALT> 2.0 x upper limit of standard value ALP> 1.5 x upper limit of standard value Total bilirubin> 1.2 x upper limit of standard value 4. Patients who are likely to start other analgesics (gabapentinoids, anticonvulsants, serotonin-noradrenaline reuptake inhibitors, hypnotic sedatives, anxiolytics, opioids) during the study period and change doses 5. Pregnant or potentially pregnant patients, lactating patients 6. Other patients who are judged to be inappropriate by the investigator and the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average weekly pain score [NRS (numerical rating scale): 0 (no pain) to 10 (worst imaginable pain) ) Evaluate on a scale of 11] when mirogabalin 0.05% topical agent was administered to patients with neuropathic pain three times a day. Compare the amount of change from baseline with the placebo group | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the proportion of subjects with a weekly mean pain score of 30% or more and 50% or more lower than baseline in the mirogabalin 0.05% topical group compared to the placebo group. | — |
Contacts
Public ContactTakeshi Takayanagi
Fujita Health University Hospital
Outcome results
None listed