E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lower limb amputation pain: phantom limb pain and primary/secondary scar hyperalgesia. |
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E.1.1.1 | Medical condition in easily understood language |
Lower limb aputation pain. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
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 |
The main objective of the trial is to investigate if a lidocaine patch 5% is effective for reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent peripheral nociceptive input from the stump after surgery may drive maladaptive cortical reorganization leading to chronic central pain and thus promote chronic phantom limb pain. Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of peripheral nociceptive afferents and thus decrease the likehood of developing persistent phantom limb pain. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All above or below knee amputations in the first two months after surgery, after complete wound healing (no clips, no stitches, no seepage) |
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E.4 | Principal exclusion criteria |
- individuals younger than 18 years old
- patients with history of central nervous system disease
- patients with history of major psychiatric disease (MMS<23/30, HADS <8/21)
- pregnancy
- known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
- skin irritation of the stump |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Reported overall daily pain intensity (stump, scar and PLP) rated on a 0 to 100 visual analogue scale with anchors of 0 (no pain) and 100 (worst pain ever experienced).
- DN4 questionnaire (screening for neuropathic pain)
- Neuropathic Pain Symptom Inventory (NPSI)
- Short-Form McGill Pain Questionnaire sentitive to the effects of pain treatment
- Quality of life: SF-36 questionnaire
- Pittsburgh Sleep Quality Index |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Reported overall daily pain intensity: every day, starting from J-7 before patch placement till 6 weeks after patch placement.
- DN4: at baseline (J-7 before placement of the patch)
- NPSI: at baseline (J-7 before placement of the patch), one day, 6 weeks and 6 month after patch placement
- McGill: at baseline (J-7 before placement of the patch), one day and 6 weeks after patch placement
-SF-36: at baseline (J-7 before placement of the patch), 6 weeks and 6 month after patch placement
- Pittsburgh Sleep Quality Index; at baseline (J-7 before placement of the patch), 6 weeks and 6 month after patch placement. |
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E.5.2 | Secondary end point(s) |
- Delay of dress of provisory prosthesis (number of days between surgery and delivery of temporary prosthesis)
- Delay of dress of provisory prosthesis (number of days between study inclusion and delivery of temporary prosthesis)
- Cumulative analgesic consumption score (CACS)
- Phantom pain occurence |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- CACS: at baseline (J-7 before placement of the patch), one day and six weeks after patch placement
- Phantom pain occurence: 6 months after patch placement |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |