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

Phase 4

Completed

• Conditions: Diabetic Neuropathy; Diabetic Complications Neurological; Diabetic Nerve Problems
• Interventions: Drug: Lidocaine 5% patch; Drug: Capsaicin 8% Patch, Per 10 Square Centimeters

• Registration Number: NCT04238208
• Lead Sponsor: Corporacion Parc Tauli

Brief 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

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-12-10
• Status Verified: 2020-01
• Study Completion: 2020-01-02
• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-19
• Study First Posted: 2020-01-23
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 290

Inclusion Criteria

• Males aged 40 - 60
• Type 2 diabetes of >10 years duration
• Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)

Exclusion Criteria

• Diabetic foot ulcer
• Deformed or contracted foot
• Neurological complications
• Presence of neurological disease
• Presence of cardiovascular or peripheral vascular disease,
• Usage of topical analgesics or implanted medical device six weeks prior to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group LP	Lidocaine 5% patch	Group LP received an identical placebo patch
Group LL	Lidocaine 5% patch	Group LL patients received the 5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm containing 700 mg of Lidocaine for 60 minutes
Group LC	Capsaicin 8% Patch, Per 10 Square Centimeters	Group LC received the 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).

Primary Outcome Measures

Name	Time	Method
Outcome 1 Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores	24 weeks	Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores. diabetes at its worst over the past 24 hours").; Each BPI item uses a 0-10 numeric rating scale anchored at zero for "no pain" and 10 for "pain as bad as you can imagine" for Severity, and "does not interfere" to "completely interferes" for Interference.
Outcome 2 Patient Global Impression of Change score	24 weeks	Patient Global Impression of Change score. PGIC is a 7 point scale depicting a patient's rating of overall improvement. The PGIC was patient-reported, and asked the subject to "indicate how you feel now, compared to how you felt before receiving treatment in this study" on a 7-point scale of -3 (very much worse), 0 (no change), to +3 (very much improved).

Trial Locations

Locations (1)

Zainab Khan; 🇵🇰 Lahore, Punjab, Pakistan