E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic neuropathic pain following limb amputation |
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E.1.1.1 | Medical condition in easily understood language |
Chronic nerve pain following the amputation of a limb |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054095 |
E.1.2 | Term | Neuropathic pain |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
E.1.2 | Term | Nervous system disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 the pre-operative application of topical Qutenza (capsaicin 8%)to patients undergoing amputation reduce chronic nerve pain at 12 weeks post-operatively? |
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E.2.2 | Secondary objectives of the trial |
Does the application of Qutenza prior to amputation reduce pain in the early post-operative period?
Does Qutenza have any effect on wound healing post-amputation?
Are there any adverse effects of topical Qutenza in patients undergoing amputation? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All adult patients (18 years and over) undergoing amputation of a lower limb |
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E.4 | Principal exclusion criteria |
1. Failure/ inability to consent 2. Local dermatological conditions/ broken skin 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, placebo, Emla or any of the excipients 6. Emergency surgery requiring to be undertaken within 24 hours of hospital admission 7. Women who are pregnant or breast-feeding 8. Diabetic neuropathy resulting in loss of sensation 9. Significant infection pre-operatively 10. Traumatic amputation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Chronic pain, as assessed by the Visual Analogue Pain Score, at 12 weeks |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Chronic neuropathic pain as assessed by the Brief Pain Inventory at 12 weeks Acute post-operative pain as assessed by VAS at 1, 3 and 7 days post-operatively Safety and tolerability Quality of life assessed by EQ-5D at 6 and 12 weeks and Patient Global Impression of Change at 12 weeks Wound healing at 7 days |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Early post-operative pain will be defined as pain within the first week (assessed day 1, day 3 and day 7) Adverse effects will be examined throughout the duration of the study Wound healing will be assessed at 7 days Quality of Life measures will be obtained at 6 weeks and 3 months post-operatively |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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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 |