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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04238208
Other study ID # LIDCAI38920
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 10, 2019
Est. completion date January 2, 2020

Study information

Verified date January 2020
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date January 2, 2020
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Zainab Khan Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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