Topical treatment of nerve pain due to poor blood flow in patients with kidney failure

Phase 1

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; Chronic pain from critical limb ischaemia in patients with end-stage renal failure; MedDRA version: 20.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852

• Registration Number: EUCTR2012-001586-32-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Study Completion: 2014-07-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

1. End stage renal failure on dialysis
2. Digital critical ischaemia defined as rest pain most days for > 3months
3. >18 years old
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Failure/ inability to consent
2. Local dermatological conditions/ broken skin/ ulceration/ tissue loss at the site of intended drug application
3. Uncontrolled hypetension (systolic BP >200)
4. Proven recent cardiac event within the past 3 months
5. Hypersensitivity to the active substance, Emla or any of the excipients
6. Women who are pregnant or breast feeding
7. Diabetic neuropathy resulting in loss of sensation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does Qutenza (topical capsaicin 8%) reduce the chronic pain from digital critical ischaemia in patients with end stage renal failure?;<br> Secondary Objective: Does Qutenza improve quality of life in patients with digital critical ischaemia and end stage renal failure?<br><br> Is Qutenza safe to use for the treatment of digital critical ischaemia in patients with end stage renal failure?<br> ;Primary end point(s): Change in pain, as assessed by visual analogue score, at 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1 week, 6 weeks and 12 weeks;<br> Secondary end point(s): •Change in pain as assessed by Brief Pain Inventory (BPI) at 12 weeks<br> * Change in pain as assessed by VAS at 1 and 6 weeks<br> •Quality of life as assessed by EQ-5D scores at 6 weeks and 12 weeks<br> •Visual Analogue Pain Scores at 1 week and 6 weeks<br> •Patient Global Impression of Change Scale at 12 weeks<br> •Adverse reactions<br>