E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic neuropathic pain from arteriovenous fistulae in patients with end stage renal failure |
|
E.1.1.1 | Medical condition in easily understood language |
Nerve pain from fistula in patients with kidney failure |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Does treatment with Qutenza (topical capsaicin 8%) reduce chronic pain from arteriovenous fistulae in patients with end stage renal disease? |
|
E.2.2 | Secondary objectives of the trial |
Does Qutenza improve quality of life in patients with chronic neuropathic pain from their AVF and end stage renal failure?
Is Qutenza safe to use for the treatment of chronic neuropathic pain arising from their AVF in patients with end stage renal failure? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. End stage renal failure on dialysis 2. Chronic neuropathic pain arising from the AVF (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)without underlying cause 3. ≥ 18 years old |
|
E.4 | Principal 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 or any of the excipients 6. Women who are pregnant or breast feeding 7. Diabetic neuropathy resulting in loss of sensation 8. Current or within 3 months participation in another clinical trial 9. Declines participation 10. Underlying structural or anatomical abnormality within the AVF contributing to the pain |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in pain, as assessed by visual analogue pain score, at 12 weeks |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
• Change in pain as assessed by Brief Pain Inventory (BPI) at 12 weeks * Change in pain as assessed by VAS at 1 and 6 weeks • Quality of life as assessed by EQ-5D scores at 6 weeks and 12 weeks • Visual Analogue Pain Scores at 1 week and 6 weeks • Patient Global Impression of Change Scale at 12 weeks • Adverse reactions
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 week, 6 weeks, 12 weeks |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 1 |