Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
Participants of either sex, aged 18 to 75 years.
Be able to understand and agree to participate in the study, undergo the procedures, and attend the visits, as indicated by signing the informed consent form approved by the CEP/Conep System.
diabetes mellitus (type 1 or 2), with glycated hemoglobin (HbA1c) levels ≤ 11%, documented symptoms of peripheral diabetic neuropathy for at least 6 months, and use of medication for glycemic control at a stable dose for at least 30 days.
postherpetic neuralgia, with pain symptoms for at least 3 months following a skin rash due to an acute episode of herpes zoster.
The presence of pain unrelated to the primary diagnosis of diabetic peripheral neuropathy or postherpetic neuralgia that could interfere with the evaluation.
Any skin condition that potentially alters sensation in the affected dermatome or area of neuropathic involvement, which could interfere with the assessment.
Having undergone neurosurgical therapy for the treatment of neuropathy.
Current use, or use within the past 7 days, of nerve block therapy and/or medications commonly used to treat neuropathic pain (e.g., benzodiazepines, skeletal muscle relaxants, capsaicin, local anesthetics, opioids, memantine), antiepileptic drugs (e.g., carbamazepine, clonazepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin), antidepressants (e.g., tricyclics, serotonin reuptake inhibitors, venlafaxine), and potential neurotoxins (e.g., hydroxychloroquine, deferoxamine, thioridazine, vigabatrin).