drugset / Trial / NCT06383702

A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy

NCT06383702

Phase 3 Unknown 358 enrolled CSPC Ouyi Pharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.

Timeline

Start
2024-05-15
Primary completion
2025-04-01
Completion
2025-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 330 mg