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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04238208
Recruitment Status : Completed
First Posted : January 23, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Zainab Khan, 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

Condition or disease Intervention/treatment Phase
Diabetic Nerve Problems Diabetic Neuropathy Diabetic Complications Neurological Drug: Lidocaine 5% patch Drug: Capsaicin 8% Patch, Per 10 Square Centimeters Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This present study was a double blinded, placebo controlled, parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : January 10, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Capsaicin patch




Primary Outcome Measures :
  1. 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.


  2. 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).



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male only
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238208


Locations
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Pakistan
Zainab Khan
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Corporacion Parc Tauli
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Responsible Party: Dr Zainab Khan, Consultant, Endocrinology Unit, Department of Internal Medicine., Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04238208    
Other Study ID Numbers: LIDCAI38920
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) can be provided by the author upon reasonable request

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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
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Complications
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
Capsaicin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents