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

Corporacion Parc Tauli290 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

290

Conditions

Diabetic Nerve Problems Diabetic Neuropathy

Interventions

Lidocaine 5% patchDRUG

5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm

Capsaicin 8% Patch, Per 10 Square CentimetersDRUG

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)

Eligibility

Sex: MALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Outcome 1 Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores

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.

Time frame: 24 weeks

Outcome 2 Patient Global Impression of Change score

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).