Phase II, single centre, randomised, double-blind, placebo-controlled study to determine the efficacy, safety and tolerability of PSD502 in the management of pain in subjects undergoing treatment for acute minor burns

Plethora Solutions Limited0 个研究点目标入组 50 人开始时间: 2005年12月8日最近更新: 2012年4月18日

适应症

试验速览

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•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.
•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) yes
•F.1.3.1 Number of subjects for this age range

•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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