Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae
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|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
Single treatment with Qutenza (topical capsaicin8%) transdermal patch
Other Name: Topical capsaicin 8%
- Neuropathic pain [ Time Frame: 12weeks ]As assessed by Visual Analogue Pain Score
- Neuropathic pain [ Time Frame: 1 week, 6 weeks ]As assessed by Visual Analogue Pain Score and Brief Pain Inventory
- Quality of life [ Time Frame: 6 weeks, 12 weeks ]As assessed by EQ-5D
- Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ]As assessed by: Number of adverse reactions.
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 ClinicalTrials.gov identifier (NCT number): NCT01748422
|Contact: Marc Clancy, PhD FRCS||0141 451 6210||Marc.Clancy@ggc.scot.nhs.uk|
|Contact: Patrick K Kearns, MBChB||0141 451 6210||Patrickkearns@nhs.net|
|Department of Renal Surgery, Queen Elizabeth University Hospital||Recruiting|
|Glasgow, Lanarkshire, United Kingdom, G51 4TF|
|Contact: Marc Clancy, FRCS PhD 0141 451 6210 Marc.Clancy@ggc.scot.nhs.uk|
|Contact: Patrick K Kearns, MBChB 0141 452 2423 Patrickkearns@nhs.net|
|Principal Investigator: Patrick K Kearns, MBChB|
|Sub-Investigator: Emma L Aitken, MBChB|
|Principal Investigator: Marc Clancy, MBChB|
|Principal Investigator:||Patrick K Kearns, MBChB||NHS Greater Glasgow and Clyde|
|Principal Investigator:||Marc Clancy, FRCS, PhD||NHS Greater Glasgow and Clyde|