EUCTR2005-004652-13-GB进行中（未招募）不适用
Phase II, multi centre, randomised, double blind, placebo controlled, pilot study to determine efficacy, safety, tolerability and preliminary pharmacokinetics of PSD502 in the management of pain from donor sites in subjects undergoing skin grafts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be considered suitable for the study if he or she fulfils all of the following criteria:
- •1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II, see Appendix IV of the protocol) with burns that require skin grafts.
- •2. Scheduled to have skin grafted from one or two donor sites.
- •3. Aged 18 - 75 years inclusive.
- •4. Normal clinical examination (except for burns).
- •5. Able to understand and complete the VAPS form.
- •6. 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
排除标准
- •A subject who fulfils any of the following criteria is excluded from the study:
- •1. Skin grafted from three or more donor sites.
- •2. Receipt of another investigational product within 3 months prior to screening.
- •3. Known hypersensitivity to amide-type local anaesthetics, or other known drug allergies.
- •4. Requirement for amide local anaesthetics pre- or intra-operatively. Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn.
- •5. Clinically relevant abnormality on ECG, in the opinion of the investigator, such as prolonged QTc.
- •6. History of alcohol or drug abuse.
- •7. Clinically significant abnormal blood biochemistry or haematology, in the opinion of the investigator.
- •8. History of psychiatric illness, from vulnerable groups, or have learning difficulties.
- •9. Female subjects who are pregnant or lactating.
- •10. Sexually active females 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).
- •11. Currently taking, or have taken within the 2 weeks prior to screening, 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.
- •12. Have taken paracetamol within 2 hours of receiving study treatment.
- •13. Known liver disease, known renal disease or heart failure.
- •Additional Exclusion Criterion for Part 2
- •14. Size of donor site(s) exceeds the area that can be covered by the maximum dose (See Appendix V of the protocol).
研究者
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