Qutenza for Critical Ischaemia in End Stage Renal Failure

This study is not yet open for participant recruitment.
Verified October 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01704339
First received: October 8, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being delivered to the tissues. It normally affects the hands and feet and can be very debilitating. It is particularly common and difficult to treat in patients with end stage renal failure

Patients with renal failure are often high risk of any operative intervention which might help the pain. Often the only treatment options are painkillers. Unfortunately however, the commonly used painkillers, for example morphine, are known to cause worse 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 painful ischaemia. We will recruit 20 patients with painful ischaemia and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.


Condition Intervention Phase
End Stage Renal Failure
Neuropathic Pain
Drug: QUTENZA
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Critical Ischaemia 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:
  • Chronic neuropathic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Chronic neuropathic pain as assessed by Visual Analogue Pain Score


Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As assessed by Brief Pain Inventory

  • Quality of Life [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Assessed using EQ-5D score

  • Neuropathic pain [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
    As assesses by Visual Analogue Pain Score

  • Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As assessed by Patient Global Impression of Change score

  • Safety and tolerability [ Time Frame: 1 day, 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: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QUTENZA
Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch
Drug: QUTENZA
Single treatment with topical capsaicin 8%
Other Name: Topical capsaicin 8%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients > 18 years old with end stage renal disease on dialysis and critical ischaemia defined as rest pain most days for >3 months

Exclusion Criteria:

  • Pre-dialysis
  • 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
  • Diabetic neuropathy resulting in a loss of sensation
  • Lack of capacity or inability to provide informed consent
  • Declines participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704339

Contacts
Contact: Emma L Aitken, MBChB 01412111750 EmmaAitken@nhs.net
Contact: David B Kingsmore, MBChB FRCS 01412111750 david.kinsgmore@ggc.scot.nhs.uk

Locations
United Kingdom
Department of Renal Surgery, Western Infirmary Not yet recruiting
Glasgow, United Kingdom, G116NY
Contact: Emma L Aitken, MBChB    01412117150    EmmaAitken@nhs.net   
Contact: David B Kingsmore, MBChB FRCS    01412111750    david.kingsmore@ggc.scot.nhs.uk   
Principal Investigator: Emma L Aitken, MBChB         
Sub-Investigator: David B Kingsmore, MBChB FRCS         
Sponsors and Collaborators
Emma Aitken
Investigators
Principal Investigator: Emma L Aitken, MBChB NHS Greater Glasgow and Clyde
  More Information

No publications provided

Responsible Party: Emma Aitken, Clinical Research Fellow, Renal Surgery, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01704339     History of Changes
Other Study ID Numbers: GN12RE072, 2012-001586-32
Study First Received: October 8, 2012
Last Updated: October 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
UK: Research Ethics Committee
UK: National Health Service

Keywords provided by NHS Greater Glasgow and Clyde:
End stage renal failure
Neuropathic pain
Critical digital ischaemia

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Ischemia
Neuralgia
Pathologic Processes
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 April 15, 2014