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Clinical Trials/NCT01748422
NCT01748422UnknownNot Applicable

The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure

NHS Greater Glasgow and Clyde1 site in 1 country20 target enrollmentStarted: November 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Neuropathic pain

Study Overview

Brief Summary

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc.

Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before.

We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All adult patients >18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (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)

Exclusion Criteria

  • Pre-dialysis
  • Underlying anatomical/ structural abnormality with AVF contributing to pain
  • Diabetic neuropathy resulting in sensory loss
  • Hypersensitivity to Qutenza, Emla or any of the excipients
  • Broken skin or active ulceration at the site of application
  • Severe uncontrolled hypertension (systolic BP >200)
  • Proven cardiac event during the preceding 3 months
  • Women who are pregnant or breast feeding
  • Lack of capacity or inability to provide informed consent
  • Declines participation in the study

Arms & Interventions

Experimental: Qutenza

Single treatment with Qutenza (topical capsaicin8%) transdermal patch

Intervention: Qutenza (Drug)

Outcomes

Primary Outcomes

Neuropathic pain

Time Frame: 12weeks

As assessed by Visual Analogue Pain Score

Secondary Outcomes

  • Neuropathic pain(1 week, 6 weeks)
  • Safety and tolerability(1 week, 6 weeks and 12 weeks)
  • Quality of life(6 weeks, 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Patrick Kearns

Principal Investigator

NHS Greater Glasgow and Clyde

Study Sites (1)

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