drugset / Trial / NCT04238208
The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capsaicin | Small molecule | 179 mg | Topical |
| Comparator | Lidocaine | Other / unclassified | 700 mg | Topical |