drugset / Trial / NCT01332149

Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

NCT01332149

Phase 3 Completed 626 enrolled Viatris Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy. This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.

Timeline

Start
2011-07
Primary completion
2014-04
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 300 mg