Creation of a healthy volunteer model of neuropathic pain. MedDRA version: 9.1 Level: SOC Classification code 10029205
Conditions
Interventions
Trade Name: capsaicina
Pharmaceutical Form: Cream
Other descriptive name: capsaicin
Concentration unit: % percent
Concentration type: equal
Concentration number: .075-
Sponsors
AZIENDA OSPEDALIERA G. BROTZU
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To evaluate the test-retest reliability in terms of spontaneous pain and mechanical allodynia.;Primary end point(s): • Heat Pain Perception Threshold (?C) • Heat Pain Tolerance Threshold (?C) | — |
Countries
Italy
Outcome results
None listed