MedDataX Logo

Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

NCT ID: NCT01748422

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain Arteriovenous Fistulae

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neuropathic pain Arteriovenous fistulae End stage renal disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Qutenza

Single treatment with Qutenza (topical capsaicin8%) transdermal patch

Qutenza

Intervention Type DRUG

Transdermal patch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Qutenza

Transdermal patch

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Topical capsaicin 8%

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Patrick Kearns

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick K Kearns, MBChB

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Marc Clancy, FRCS, PhD

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Renal Surgery, Queen Elizabeth University Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marc Clancy, PhD FRCS

Role: CONTACT

Phone: 0141 451 6210

Email: [email protected]

Patrick K Kearns, MBChB

Role: CONTACT

Phone: 0141 451 6210

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marc Clancy, FRCS PhD

Role: primary

Patrick K Kearns, MBChB

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GU11SB126

Identifier Type: -

Identifier Source: org_study_id