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Qutenza for Critical Ischaemia in End Stage Renal Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Emma Aitken, NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704339
First Posted: October 11, 2012
Last Update Posted: October 11, 2012
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.
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde
  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: Intervention Model: Single Group Assignment
Masking: None (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 Emma Aitken, NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Chronic neuropathic pain [ Time Frame: 12 weeks ]
    Chronic neuropathic pain as assessed by Visual Analogue Pain Score


Secondary Outcome Measures:
  • Neuropathic pain [ Time Frame: 12 weeks ]
    As assessed by Brief Pain Inventory

  • Quality of Life [ Time Frame: 6 weeks, 12 weeks ]
    Assessed using EQ-5D score

  • Neuropathic pain [ Time Frame: 1 week, 6 weeks ]
    As assesses by Visual Analogue Pain Score

  • Quality of Life [ Time Frame: 12 weeks ]
    As assessed by Patient Global Impression of Change score

  • Safety and tolerability [ Time Frame: 1 day, 12 weeks ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Submitted: October 8, 2012
First Posted: October 11, 2012
Last Update Posted: October 11, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Ischemia
Neuralgia
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs