E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To evaluate the efficacy of PSD502 compared with placebo in relieving pain from acute minor burns, as assessed by visual analogue pain scale (VAPS), during immediate burns management. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of PSD502. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects who fulfil all of the following criteria will be eligible for the study: 1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II – Appendix IV of protocol) subjects with acute first degree burns on ≤5% body surface area that may or may not require de-roofing but do require cleaning and application of a dressing. 2. Subjects with single or multiple burns on only one part of the body, i.e. all burns at a single site of assessment 3. Subjects whose burns have cause predominantly superficial dermal injury and whose burns can be treated on an outpatient basis. 4. Subjects whose burn injury has occurred within 72 hours of the subject attending the clinic. 5. Subjects who have been given a standard dose of oral morphine (approximately 0.2-0.4 mg/kg) as routine management prior to treating the burn. 6. Subjects aged 18 - 75 years inclusive. 7. Subjects with normal clinical examination (except for burns). 8. Subjects who are able to understand and complete the VAPS form. 9. Subjects who are willing and able to provide written informed consent.
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E.4 | Principal exclusion criteria |
Subjects who fulfil any of the following criteria will be excluded from the study: 1. Subjects whose burn injury has been previously debrided. 2. Subjects with facial burns or with burns sites on more than one part of the body. 3. Subjects who have received another investigational product within the previous 3 months. 4. Subjects with known hypersensitivity to amide-type local anaesthetics, or other known drug allergies. 5. Subjects who have taken analgesics, including paracetamol, within 2 hours of enrolment into the study, or an opiate within 4 hours prior to enrolment into the study (other than a standard dose of oral morphine on admission to the unit). 6. Subjects with a history of alcohol or drug abuse. 7. Female subjects who are pregnant or lactating. 8. Sexually active female subjects who are of child-bearing potential (<2 years post menopausal) and not using a reliable method of contraception (oral, injectable or implantable contraceptives, barrier methods of contraception, or surgically sterile). 9. Subjects who are currently taking, or have taken within the previous 2 weeks, any of the following medications: acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates (including glyceryl trinitrate), nitrites, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, or sulfonamides. 10. Known liver disease, known renal disease or heart failure.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Pain will be assessed by subjects using a 100 mm VAPS. The primary efficacy variable is the retrospective VAPS to assess pain felt during the procedure by PSD502 and placebo-treated subjects. The secondary efficacy variable is the change from pre-dose in the mean VAPS score from 0.25 to 2 hours post-treatment to assess pain felt at the burn site for PSD502 and placebo-treated subjects. Safety: Adverse events and any serious adverse events will be recorded throughout the study. Routine safety monitoring will include vital signs (heart rate, blood pressure, respiratory rate) at screening (pre-dose), 0.5 and 2 hours after dosing.
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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 | Yes |
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 | Information not present in EudraCT |
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 |
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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) | 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.8.3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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each subject will receive a single dose |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |