Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

NCT01748422 | Unknown

• 1 other identifier: GU11SB126
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Arteriovenous Fistulae

Keywords

Neuropathic pain; Arteriovenous fistulae; End stage renal disease

Outcome Measures

Primary Outcomes (1)

• Neuropathic pain

  As assessed by Visual Analogue Pain Score

  12weeks

Secondary Outcomes (3)

• Neuropathic pain

  1 week, 6 weeks

• Quality of life

  6 weeks, 12 weeks

• Safety and tolerability

  1 week, 6 weeks and 12 weeks

Study Arms (1)

Experimental: Qutenza

Single treatment with Qutenza (topical capsaicin8%) transdermal patch

Drug: Qutenza

Interventions

Qutenza DRUG

Transdermal patch

Also known as: Topical capsaicin 8%

Experimental: Qutenza

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Department of Renal Surgery, Queen Elizabeth University Hospital

Glasgow, Lanarkshire, G51 4TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuralgia; Kidney Failure, Chronic

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Patrick K Kearns, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Marc Clancy, FRCS, PhD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Clancy, PhD FRCS

CONTACT

0141 451 6210; Marc.Clancy@ggc.scot.nhs.uk

Patrick K Kearns, MBChB

CONTACT

0141 451 6210; Patrickkearns@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

GB (1)