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

January 28, 2020 updated by: Dr Zainab Khan, Corporacion Parc Tauli

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Zainab Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Lidocaine 5% patch
5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm
Other Names:
  • Lidocaine patch
Placebo Comparator: Group LP
Group LP received an identical placebo patch
Drug: Lidocaine 5% patch
5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm
Other Names:
  • Lidocaine patch
Experimental: 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).
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)
Other Names:
  • Capsaicin patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome 1 Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores
Time Frame: 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.
24 weeks
Outcome 2 Patient Global Impression of Change score
Time Frame: 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).
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

January 2, 2020

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIDCAI38920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data (IPD) can be provided by the author upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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