Neuropathic PainNCT01748422
Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae
An observational study of Neuropathic Pain and Arteriovenous Fistulae, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuropathic Pain, Arteriovenous Fistulae
- What is being tested?
- Qutenza
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae
Who may be able to join
- All adult patients >18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)
Who cannot join
- Pre-dialysis
- Underlying anatomical/ structural abnormality with AVF contributing to pain
- Diabetic neuropathy resulting in sensory loss
- 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)
Show all 10Show fewer
- Proven cardiac event during the preceding 3 months
- Women who are pregnant or breast feeding
- Lack of capacity or inability to provide informed consent
- Declines participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Renal Surgery, Queen Elizabeth University Hospital
Glasgow, Lanarkshire, G51 4TF
Marc Clancy, FRCS PhD, 0141 451 6210, Marc.Clancy@ggc.scot.nhs.uk
Patrick K Kearns, MBChB, 0141 452 2423, Patrickkearns@nhs.net
About this study
Official title: The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure
Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant 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 chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.
- Conditions
- Neuropathic Pain, Arteriovenous Fistulae
- Being tested
- Qutenza
- Keywords
- Neuropathic pain, Arteriovenous fistulae, End stage renal disease
- Medical subject headings
- Neuralgia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QutenzaDrug
Also called Topical capsaicin 8%
Transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Qutenza | Single treatment with Qutenza (topical capsaicin8%) transdermal patch Receives: Drug: Qutenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain
As assessed by Visual Analogue Pain Score
Measured: 12weeks
Secondary outcomes (3)
Neuropathic pain
As assessed by Visual Analogue Pain Score and Brief Pain Inventory
Measured: 1 week, 6 weeks
Quality of life
As assessed by EQ-5D
Measured: 6 weeks, 12 weeks
Safety and tolerability
As assessed by: Number of adverse reactions.
Measured: 1 week, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Patrick Kearns, NHS Greater Glasgow and Clyde
- Investigators
- Patrick K Kearns, MBChB, Principal investigator, NHS Greater Glasgow and ClydeMarc Clancy, FRCS, PhD, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748422
- Sponsor's protocol ID
- GU11SB126
- Status last verified
- Nov 2016
- First submitted
- 10 Dec 2012
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure
- ClinicalTrials.gov ID
- NCT01748422
- Acronym / sponsor ID
- GU11SB126
- Conditions
- Neuropathic Pain, Arteriovenous Fistulae
- Keywords
- Neuropathic pain, Arteriovenous fistulae, End stage renal disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant 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 chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Qutenza | – | Drug: QutenzaSingle treatment with Qutenza (topical capsaicin8%) transdermal patch |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae
Key inclusion criteria (1 listed)
- All adult patients >18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)
Key exclusion criteria (10 listed)
- Pre-dialysis
- Underlying anatomical/ structural abnormality with AVF contributing to pain
- Diabetic neuropathy resulting in sensory loss
- Hypersensitivity to Qutenza, Emla or any of the excipients
- Broken skin or active ulceration at the site of application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QutenzaAlso: Topical capsaicin 8%Transdermal patch | Drug | Experimental: Qutenza |
Primary outcome
Neuropathic pain
Time frame: 12weeks
As assessed by Visual Analogue Pain Score
3 secondary outcomes
Neuropathic pain
Time frame: 1 week, 6 weeks
Quality of life
Time frame: 6 weeks, 12 weeks
Safety and tolerability
Time frame: 1 week, 6 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick K Kearns, MBChB principal investigator
NHS Greater Glasgow and Clyde
Marc Clancy, FRCS, PhD principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Arteriovenous Fistulae, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Clancy, PhD FRCS (0141 451 6210, Marc.Clancy@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.