drugset / Trial / NCT04238208

The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy

NCT04238208

Phase 4 Completed 290 enrolled Corporacion Parc Tauli
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Timeline

Start
2019-01-10
Primary completion
2019-12-10
Completion
2020-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Capsaicin Small molecule 179 mg Topical
Comparator Lidocaine Other / unclassified 700 mg Topical