ISRCTN18863931CompletedPhase 2
Phase II, multi-centre, randomised, two-part pilot study (Part 1 open, uncontrolled; Part 2 double-blind, placebo controlled) to determine the efficacy, safety, tolerability and preliminary pharmacokinetics of PSD502 in the management of pain from donor sites in burns subjects undergoing skin grafts
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Plethora Solutions Ltd
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II) 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
Exclusion Criteria
- •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 Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn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
Investigators
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