E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Creation of a healthy volunteer model of neuropathic pain. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
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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 assess the use of capsaicin cream (0.075%) as model of neuropathic pain in humans, evaluating the test-retest reliability in terms of thermal hyperalgesia. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the test-retest reliability in terms of spontaneous pain and mechanical allodynia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult male or female between 18 and 64 years of age inclusive. 2. Body weight ≥ 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive. 3. No clinically significant abnormality identified on the medical or laboratory evaluation (performed within 3 months). A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. 4. Normal Vital Parameters (BP and HR) at the screening visit. 5. Not clinically significant 12-lead ECG reading at the screening visit. 6. Sensitivity to topical capsaicin, defined as a reduction in heat pain threshold of at least 2 oC following application of capsaicin cream to the skin for 30 minutes. 7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. |
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E.4 | Principal exclusion criteria |
1. Positive drug/alcohol screen before the capsaicin test. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. 2. History of psychiatric illness. 3. History of regular alcohol consumption within 6 months of the study defined as: • an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. 4. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the study day, unless in the opinion of the Investigator the medication will not interfere with the study procedures. 5. Over-the-counter (OTC) analgesic medicine taken within 48 hours or 5 half-lives whichever is longer before the first dosing day unless, in the opinion of the Principal/Co-Investigator, the medication received do not interfere with the study procedures or compromise safety. 6. A total score above 100 or/and a medical pain subscale score above 30 with “Fear of Pain Questionnaire-III” 7. Known hypersensitivity to capsaicin. 8. Recent history (<6 months) of prolonged (>1 wk) use of capsaicin-containing preparations on the skin of the forearms. 9. Use of capsaicin cream or other topical capsaicin preparations within 1 week on the skin of the forearms. 10. Any history of a clinically significant abnormality of the neurological sensitive system of forearms. 11. High probability of technical problems with capsaicin test, e.g., tattoos on forearms, highly pigmented skin. 12. Assumption of an investigational product within the following time period prior to the first dosing day in the current study: 6 months. 13. Unwillingness or inability to follow the procedures outlined in the protocol. 14. Vulnerable subject (e.g. kept in detention). 15. Pregnant Female. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Heat Pain Perception Threshold (�C) • Heat Pain Tolerance Threshold (�C) |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Studio di messa a punto di un modello |
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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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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La studio sara` concluso quando l`ultimo degli 8 volontari arruolati avra` completato le 2 sessioni di studio e il follow up telefonico previsto 1 settimana dopo la seconda sessione di studio. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |