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NCT Number: NCT04238208

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

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

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Key information

Conditions

Diabetic Nerve Problems Diabetes Complications Diabetes Mellitus Diabetic Complications Neurological Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Zainab Khan

Lahore, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine 5% patch

Drug

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

Other names: Lidocaine patch

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)

Other names: Capsaicin patch

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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