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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetic Nerve Problems, Diabetic Neuropathy, Diabetic Complications Neurological

Intervention / Treatment
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* Drug: Lidocaine 5% patch
* Drug: Capsaicin 8% Patch, Per 10 Square Centimeters


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This present study was a double blinded, placebo controlled, parallel group study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group LL<br>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 | Drug: Lidocaine 5% patch<br>* 5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm<br>* Other names: Lidocaine patch;|
| Placebo Comparator: Group LP<br>Group LP received an identical placebo patch | Drug: Lidocaine 5% patch<br>* 5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm<br>* Other names: Lidocaine patch;|
| Experimental: Group LC<br>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). | Drug: Capsaicin 8% Patch, Per 10 Square Centimeters<br>* 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)<br>* Other names: Capsaicin patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 24 weeks |