Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01748422
• Other study ID #: GU11SB126
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2012
• Last updated: November 9, 2016
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: NHS Greater Glasgow and Clyde
• Contact: Marc Clancy, PhD FRCS
• Phone: 0141 451 6210
• Email: Marc.Clancy[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistulae
• Fistula
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Qutenza
Transdermal patch

Locations

Country	Name	City	State
United Kingdom	Department of Renal Surgery, Queen Elizabeth University Hospital	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic pain	As assessed by Visual Analogue Pain Score	12weeks	No
Secondary	Neuropathic pain	As assessed by Visual Analogue Pain Score and Brief Pain Inventory	1 week, 6 weeks	No
Secondary	Quality of life	As assessed by EQ-5D	6 weeks, 12 weeks	No
Secondary	Safety and tolerability	As assessed by: Number of adverse reactions.	1 week, 6 weeks and 12 weeks	Yes