Topical treatment of nerve pain arising from artery-to-vein connections in patients with kidney failure

Phase 1

• Conditions: Chronic neuropathic pain from arteriovenous fistulae in patients with end stage renal failure; MedDRA version: 20.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002266-71-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. End stage renal failure on dialysis
2. Chronic neuropathic pain arising from the AVF (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)without underlying cause
3. = 18 years old
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Failure/ inability to consent
2. Local dermatological conditions/ broken skin/ ulceration/ tissue loss at the site of intended drug application
3. Uncontrolled hypetension (systolic BP >200)
4. Proven recent cardiac event within the past 3 months
5. Hypersensitivity to the active substance or any of the excipients
6. Women who are pregnant or breast feeding
7. Diabetic neuropathy resulting in loss of sensation
8. Current or within 3 months participation in another clinical trial
9. Declines participation
10. Underlying structural or anatomical abnormality within the AVF contributing to the pain

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does treatment with Qutenza (topical capsaicin 8%) reduce chronic pain from arteriovenous fistulae in patients with end stage renal disease?;Secondary Objective: Does Qutenza improve quality of life in patients with chronic neuropathic pain from their AVF and end stage renal failure?<br><br>Is Qutenza safe to use for the treatment of chronic neuropathic pain arising from their AVF in patients with end stage renal failure?;Primary end point(s): Change in pain, as assessed by visual analogue pain score, at 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change in pain as assessed by Brief Pain Inventory (BPI) at 12 weeks<br>* Change in pain as assessed by VAS at 1 and 6 weeks<br>•Quality of life as assessed by EQ-5D scores at 6 weeks and 12 weeks<br>•Visual Analogue Pain Scores at 1 week and 6 weeks<br>•Patient Global Impression of Change Scale at 12 weeks<br>•Adverse reactions<br>;Timepoint(s) of evaluation of this end point: 1 week, 6 weeks, 12 weeks