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Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748422
Recruitment Status : Unknown
Verified November 2016 by Dr Patrick Kearns, NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : December 12, 2012
Last Update Posted : November 11, 2016
Information provided by (Responsible Party):
Dr Patrick Kearns, NHS Greater Glasgow and Clyde

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.

Condition or disease Intervention/treatment
Neuropathic Pain Arteriovenous Fistulae Drug: Qutenza

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure
Study Start Date : November 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Capsaicin

Group/Cohort Intervention/treatment
Experimental: Qutenza
Single treatment with Qutenza (topical capsaicin8%) transdermal patch
Drug: Qutenza
Transdermal patch
Other Name: Topical capsaicin 8%

Primary Outcome Measures :
  1. Neuropathic pain [ Time Frame: 12weeks ]
    As assessed by Visual Analogue Pain Score

Secondary Outcome Measures :
  1. Neuropathic pain [ Time Frame: 1 week, 6 weeks ]
    As assessed by Visual Analogue Pain Score and Brief Pain Inventory

  2. Quality of life [ Time Frame: 6 weeks, 12 weeks ]
    As assessed by EQ-5D

  3. Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ]
    As assessed by: Number of adverse reactions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748422

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Contact: Marc Clancy, PhD FRCS 0141 451 6210
Contact: Patrick K Kearns, MBChB 0141 451 6210

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United Kingdom
Department of Renal Surgery, Queen Elizabeth University Hospital Recruiting
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Contact: Marc Clancy, FRCS PhD    0141 451 6210   
Contact: Patrick K Kearns, MBChB    0141 452 2423   
Principal Investigator: Patrick K Kearns, MBChB         
Sub-Investigator: Emma L Aitken, MBChB         
Principal Investigator: Marc Clancy, MBChB         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
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Principal Investigator: Patrick K Kearns, MBChB NHS Greater Glasgow and Clyde
Principal Investigator: Marc Clancy, FRCS, PhD NHS Greater Glasgow and Clyde

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Responsible Party: Dr Patrick Kearns, Principal Investigator, NHS Greater Glasgow and Clyde Identifier: NCT01748422    
Other Study ID Numbers: GU11SB126
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dr Patrick Kearns, NHS Greater Glasgow and Clyde:
Neuropathic pain
Arteriovenous fistulae
End stage renal disease
Additional relevant MeSH terms:
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Arteriovenous Fistula
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs