Qutenza for Critical Ischaemia in End Stage Renal Failure

NCT01704339 | Unknown Phase 4

• 2 other identifiers: GN12RE0722012-001586-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Failure; Neuropathic Pain

Keywords

End stage renal failure; Neuropathic pain; Critical digital ischaemia

Outcome Measures

Primary Outcomes (1)

• Chronic neuropathic pain

  Chronic neuropathic pain as assessed by Visual Analogue Pain Score

  12 weeks

Secondary Outcomes (5)

• Neuropathic pain

  12 weeks

• Quality of Life

  6 weeks, 12 weeks

• Neuropathic pain

  1 week, 6 weeks

• Quality of Life

  12 weeks

• Safety and tolerability

  1 day, 12 weeks

Study Arms (1)

QUTENZA

EXPERIMENTAL

Single treatment with QUTENZA (topical capsaicin 8%) transdermal patch

Drug: QUTENZA

Interventions

QUTENZA DRUG

Single treatment with topical capsaicin 8%

Also known as: Topical capsaicin 8%

QUTENZA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emma Aitken: lead

Study Sites (1)

Department of Renal Surgery, Western Infirmary

Glasgow, G116NY, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Neuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Emma L Aitken, MBChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma L Aitken, MBChB

CONTACT

01412111750; EmmaAitken@nhs.net

David B Kingsmore, MBChB FRCS

CONTACT

01412111750; david.kinsgmore@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow, Renal Surgery

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

GB (1)