NCT04238208

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

The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Patients With Diabetic Peripheral Neuropathic Pain: a Randomized, Placebo-controlled Study of South Asian Male Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

The aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south Asian male 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

Conditions

• Diabetic Nerve Problems
• Diabetic Neuropathy
• Diabetic Complications Neurological

Interventions

Type	Name	Description
DRUG	Lidocaine 5% patch	5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm
DRUG	Capsaicin 8% Patch, Per 10 Square Centimeters	8% Capsaicin patch \[8% w/w\] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK)

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-12-10
• Completion: 2020-01-02
• First posted: 2020-01-23
• Last updated: 2020-01-30

Locations

1 site across 1 country: Pakistan