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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01748422
Other study ID # GU11SB126
Secondary ID
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


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
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