Comparing Extended-Release and Immediate-Release Pregabalin Tablets for Neuropathic Pain in Adults with Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

What this Trial Is About

Researchers are evaluating extended-release pregabalin tablets compared to immediate-release pregabalin tablets for treating neuropathic pain in adults with diabetic peripheral neuropathy or postherpetic neuralgia. This Phase III study aims to assess differences in pain relief over 16 weeks of treatment in patients experiencing moderate to severe neuropathic pain. Participants are randomly assigned to one of two groups. One group receives extended-release pregabalin tablets starting at 82.5 mg once daily, with dose adjustments every week up to 660 mg daily, plus a placebo twice daily. The other group receives immediate-release pregabalin tablets starting at 75 mg twice daily, with dose adjustments up to 300 mg twice daily, plus a placebo once daily. Dose adjustments occur during the first four weeks. During the study, participants will record their pain intensity daily and attend regular visits for up to 16 weeks. Researchers will measure changes in pain intensity, improvements in sleep, quality of life, anxiety and depression symptoms, and the use of rescue medication. The primary outcome is the difference in mean pain intensity after 16 weeks compared to baseline. Safety and overall participant perception of change will also be monitored throughout the study.

Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia