Qutenza for Painful Fistulae

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01748422
First received: December 10, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysisin patients wit hkidney 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 Intervention
Neuropathic Pain
Arteriovenous Fistulae
Drug: Qutenza

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Neuropathic pain [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
    As assessed by Visual Analogue Pain Score


Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
    As assessed by Visual Analogue Pain Score and Brief Pain Inventory

  • Qulaity of life [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    As assessed by EQ-5D

  • Safety and tolerability [ Time Frame: 1 week, 6 weeks and 12 weeks ] [ Designated as safety issue: Yes ]
    Skin will be assessed for breaks/ blisters and tolerability, including the need for rescue analgesia will be recorded


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Experimental: Qutenza
Single treatment with Qutenza (topical capsaicin8%) transdermal patch
Drug: Qutenza
Transdermal patch
Other Name: Topical capsaicin 8%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748422

Contacts
Contact: Marc Clancy, PhD FRCS 01412111750 Marc.Clancy@ggc.scot.nhs.uk
Contact: Emma L Aitken, MBChB 01412111750 EmmaAitken@nhs.net

Locations
United Kingdom
Department of Renal Surgery, Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G116NY
Contact: Marc Clancy, FRCS PhD    01412111750    Marc.Clancy@ggc.scot.nhs.uk   
Contact: Emma L Aitken, MBChB    01412111750    EmmaAitken@nhs.net   
Principal Investigator: Marc Clancy, FRCS PhD         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: Marc Clancy, FRCS PhD NHS Greater Glasgow and Clyde
  More Information

No publications provided

Responsible Party: Emma Aitken, Clinical Research Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01748422     History of Changes
Other Study ID Numbers: GU11SB126
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: UK: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Neuropathic pain
Arteriovenous fistulae
End stage renal disease

Additional relevant MeSH terms:
Arteriovenous Malformations
Arteriovenous Fistula
Fistula
Kidney Failure, Chronic
Neuralgia
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014