E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heat injury in healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
A light heat injury in healthy volunteers |
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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 | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
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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 | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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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 |
Quantitative sensory testing in the heat injury area after melatonin/placebo-treatment.
1. Pain (VAS) during heat injury and areas of hyperalgsia
2. Pharmacokinetic and pharmacodynamic variables, plasma-concentration profiles, and hysteresis-curves with plasma-concentration (during onset og off-set) vs. effekt-variables
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Kvantitativ sensorisk testning i det varmeskadede område efter melatonin/placebo-behandling.
De primære outcome-parametre er en dosisafhængig påvirkning af smerterne under varmeskade (AUC7 min-VAS), samt påvirkning af de sekundære hyperalgesi-arealer.
Outcomes Bestemmelse af traditionelle farmakokinetiske og farmakodynamiske variabler, plasma-koncentrations profiler samt hysterese-kurver med plasma-koncentration (under onset og off-set) vs. effekt-variabler er de centrale mål i studiet.
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E.2.2 | Secondary objectives of the trial |
Erythema/oedema, and thermal and mechanical thresholds of quantitative sensory testing |
Erythem/ødem, samt påvirkning af termale og mekaniske tærskler.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy males aged between 20 and 40 years |
Raske mandlige forsøgspersoner med alder mellem 20-40 år
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E.4 | Principal exclusion criteria |
Under aged/minors
Does not speak or understand danish
Alcol/medicin abuse
Prior QST-trial within the last 2 month
Prior medical trail within the last month
Serious comorbidity(ASA-class 3-4)
Chronic pain(defined by analgesic treatment)
Shift-work or night work within the last 14 days
Known sleep-disorder
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Umyndig
Forstår ikke dansk i tale eller skrift
Aktuelt alkohol/medicinmisbrug.
Deltagelse i QST-forsøg inden for de seneste 2 mdr. før første forsøgsdag
Deltagelse i medicinske forsøg inden for de seneste 1 mdr. før første forsøgsdag
Alvorlig behandlingskrævende komorbiditet (ASA-klasse 3+4) eller behandlingskrævende psykisk sygdom
Tilstand med kroniske smerter (defineret ved daglig analgetisk behandling)
Skifteholdsarbejde eller natarbejde i øvrigt i 14 dage op til forsøget.
Kendt diagnosticeret søvnforstyrrelse
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain(VAS) during heat injury and areas of hyperalgesia |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline + 1,2,3 hours postburn |
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E.5.2 | Secondary end point(s) |
Erythema and thermal/mechanical thresholds |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline + 1,2,3 hours postburn |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | 3 |
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 | Yes |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |