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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

NCT00904202

Postherpetic Neuralgia Diabetic Neuropathy Complex Regional Pain Syndrome +4 more

COMPLETED PHASE4

Tolerability of Three Local Anesthetic Formulations in Conjunction With NGX-4010 for the Treatment of Neuropathic Pain

NCT00082316

Herpes Zoster Neuralgia Pain +5 more

COMPLETED PHASE2

Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy

NCT01086150

Diabetic Peripheral Neuropathy

COMPLETED PHASE2/PHASE3

A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

NCT00904020

Postherpetic Neuralgia Diabetic Neuropathy Low Back Pain

COMPLETED PHASE4

Efficacy and Safety of Topical Versus Systemic Treatment in Postherpetic Neuralgia and Diabetic Polyneuropathic Pain

NCT00414349

Neuropathic Pain

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nerve Problems Diabetic Neuropathy Diabetic Complications Neurological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This present study was a double blinded, placebo controlled, parallel group study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blinded study, the investigators, patients and care providers were not aware of the identity of the administered patch. The codes 11 were used for the capsaicin patch, 12 for the control patch and 33 for the lidocaine patch. These codes were retained by a hospital staff member who was not involved in the study and were revealed to the researchers after all the data was collected and analyses.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group LL

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 Type ACTIVE_COMPARATOR

Lidocaine 5% patch

Intervention Type DRUG

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

Group LP

Group LP received an identical placebo patch

Group Type PLACEBO_COMPARATOR

Lidocaine 5% patch

Intervention Type DRUG

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

Group LC

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).

Group Type EXPERIMENTAL

Capsaicin 8% Patch, Per 10 Square Centimeters

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine 5% patch

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

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lidocaine patch Capsaicin patch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No