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

NCT04238208 | Completed Phase 4 DMC

• 1 other identifier: LIDCAI38920
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Nerve Problems; Diabetic Neuropathy; Diabetic Complications Neurological

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group LL

ACTIVE COMPARATOR

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

Group LP

PLACEBO COMPARATOR

Group LP received an identical placebo patch

Drug: Lidocaine 5% patch

Group LC

EXPERIMENTAL

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

Interventions

Lidocaine 5% patch DRUG

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

Also known as: Lidocaine patch

Group LL; Group LP

Capsaicin 8% Patch, Per 10 Square Centimeters 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)

Also known as: Capsaicin patch

Group LC

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Zainab Khan

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Lidocaine; Transdermal Patch; Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies; Polyunsaturated Alkamides; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Endocrinology Unit, Department of Internal Medicine.

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

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: January 10, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 2, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)