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Qutenza for Critical Ischaemia in End Stage Renal Failure

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. Identifier: NCT01704339
Recruitment Status : Unknown
Verified October 2012 by Emma Aitken, NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):
Emma Aitken, NHS Greater Glasgow and Clyde

Brief Summary:

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 or disease Intervention/treatment Phase
End Stage Renal Failure Neuropathic Pain Drug: QUTENZA Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: QUTENZA
Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch
Single treatment with topical capsaicin 8%
Other Name: Topical capsaicin 8%

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

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

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

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

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

  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01704339

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Contact: Emma L Aitken, MBChB 01412111750
Contact: David B Kingsmore, MBChB FRCS 01412111750

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United Kingdom
Department of Renal Surgery, Western Infirmary
Glasgow, United Kingdom, G116NY
Contact: Emma L Aitken, MBChB    01412117150   
Contact: David B Kingsmore, MBChB FRCS    01412111750   
Principal Investigator: Emma L Aitken, MBChB         
Sub-Investigator: David B Kingsmore, MBChB FRCS         
Sponsors and Collaborators
Emma Aitken
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Principal Investigator: Emma L Aitken, MBChB NHS Greater Glasgow and Clyde
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Responsible Party: Emma Aitken, Clinical Research Fellow, Renal Surgery, NHS Greater Glasgow and Clyde Identifier: NCT01704339    
Other Study ID Numbers: GN12RE072
2012-001586-32 ( EudraCT Number )
First Posted: October 11, 2012    Key Record Dates
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:
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Renal Insufficiency
Kidney Failure, Chronic
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs