E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CHRONIC PAIN AFTER INGUINAL HERNIOTOMY |
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E.1.1.1 | Medical condition in easily understood language |
CHRONIC PAIN AFTER INGUINAL HERNIOTOMY |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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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 |
to investigate analgesic and sensory effects of a capsaicin patch (Qutenza) in patients with severe postherniotomy pain and sensory abnormalities in the skin. |
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E.2.2 | Secondary objectives of the trial |
Investigate changes after treatment in Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), need of rescue medication (paracetamol), patient preference and Sleep Interference Scale (SIS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males > 18 yrs, ASA (American Society´s of Anesthesiology´s classification) scores I-III, with severe postherniotomy pain for more than six months and with average daily pain intensities (numerical rating scale [NRS] 0–10 points) during rest or during movement > 5. Concomitant analgesics and adjuvant analgesics will be permitted, provided that subjects have received a stable regimen for at least four weeks prior to study entry. |
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E.4 | Principal exclusion criteria |
History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches; use of class I antiarrhythmic drugs (e.g., tocainide and mexiletine); severe cardiac impairment, inflamed or injured skin at the application site; known severe hepatic disorder, known severe renal impairment, breastfeeding women, signs of cognitive impairment or known drug or ethanol abuse during the last 2 years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days during each of the study´s phases: Baseline (0SPI3d), 1 month (1SPI3d), 2 month (2SPI3d), and 3 month (3SPI3d).
The summed pain intensity differences (SPID) are calculated:
• 0SPI3d - 1SPI3d= SPID0-1
• 0SPI3d - 2SPI3d= SPID0-2
• 0SPI3d - 3SPI3d= SPID0-3
The primary outcome measure is the maximum difference between the summed pain intensity differences for the phases: Baseline, 1 month, 2 month or 3 month. ∆ SPID is then calculated as the difference in SPID between capsaicin and inactive placebo treated patients.
Identical calculations are made for patients with thermal hypoesthesia (∆ SPIDhypo) and thermal normo/hyperesthesia (∆ SPIDnormo/hyper).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain intensity (numerical rating scale [NRS] 0–10 points) is registered twice daily |
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E.5.2 | Secondary end point(s) |
Changes in Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), need of rescue medication (paracetamol), patient preference and Sleep Interference Scale (SIS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before treatment and each month during the 3 months follow-up after treatment |
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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 | No |
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) | Yes |
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
| 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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |