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

The role of Qutenza (topical capsaicin 8%) in treating neuropathic pain from arteriovenous fistulae in patients with end stage renal failure - Qutenza for painful fistulae v1.0

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002266-71-GB

Enrollment

Registered

2019-06-11

Start date

2015-01-02

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic neuropathic pain from arteriovenous fistulae in patients with end stage renal failure MedDRA version: 20.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: Qutenza Product Name: Qutenza Pharmaceutical Form: Cutaneous patch INN or Proposed INN: Capsaicin CAS Number: 404-86-4 Concentration unit: % (W/W) percent weight/weight Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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? 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	—

Measure

Time frame

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? 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

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Secondary

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

Measure

Time frame

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

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Countries

United Kingdom

Contacts

Public ContactTravers

NHS Greater Glasgow and Clyde

Maureen.Travers@ggc.scot.nhs.uk01412116389

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026