Qutenza for Critical Ischaemia in End Stage Renal Failure
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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 |
- Chronic neuropathic pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Chronic neuropathic pain as assessed by Visual Analogue Pain Score
- 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 |
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| Contact: Emma L Aitken, MBChB | 01412111750 | EmmaAitken@nhs.net |
| Contact: David B Kingsmore, MBChB FRCS | 01412111750 | david.kinsgmore@ggc.scot.nhs.uk |
| 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 | |
| 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 Ischemia Neuralgia Renal Insufficiency Pathologic Processes Renal Insufficiency, Chronic 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 May 23, 2013