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| 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 |
| ISRCTN | ISRCTN18863931 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | PSD502-PM-001 |
| Study hypothesis |
The active ingredients of PSD502, lidocaine and prilocaine, are available in aqueous formulations such as creams and gels in the hydrochloride salt form, which facilitates their water solubility. Aqueous formulations, however, have poor residency, and while this factor is optimised by the use of creams and gels, they physically impede the movement of local anaesthetic down the concentration gradient and out of the gel, through the skin or mucous membrane surface. Therefore, these preparations have not been found to be successful with a drug that requires rapid delivery of relatively high concentrations of local anaesthetic. Aerosol preparations can employ the base form of local anaesthetic compounds, thereby facilitating drug penetration.
PSD502 is expected to provide a fast onset of anaesthesia when applied to non-keratinised skin, such as skin grafts, burns, leg ulcers and grazes, or to normal mucosa and to have beneficial effects in these patients in providing pain relief with an easy to use fast acting topical spray. Therefore, the present study has been designed with the objectives of determining the efficacy of PSD502 in relieving the pain of skin graft donor sites in patients with severe burns, and the safety and tolerability of the preparation when applied to exposed dermal tissue. |
| Ethics approval | South West Multi-centre REC, approved on 01/02/2006, ref: 06/MRE06/8 |
| Study design | This is a proof of principle study that will be divided into Part 1, an uncontrolled open label study in 8 subjects, followed by Part 2, a double-blind placebo controlled study in not more than 30 subjects. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Management of pain from donor sites in burns subjects undergoing skin grafts. |
| Participants - inclusion criteria |
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) 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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/02/2006 |
| Anticipated end date | 31/10/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 8 subjects in Part 1. 30 subjects in Part 2. |
| Interventions |
PSD502 is a metered dose aerosol spray that delivers a eutectic mixture of lidocaine and prilocaine. The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant.
Part 1: Active PSD502 on one or both donor sites. Part 2: 1. PSD502 and matching placebo on those subjects with paired donor sites (randomized and double-blind). 2. PSD502 or matching placebo on those subjects with one donor site. |
| Primary outcome measure(s) | To evaluate and compare the efficacy of PSD502 with placebo in relieving pain, as assessed by visual analogue pain scale (VAPS), from skin graft donor sites. |
| Secondary outcome measure(s) |
1. To evaluate the safety and tolerability of PSD502 applied to skin graft donor sites
2. To characterise the preliminary pharmacokinetics of PSD502 3. To evaluate and compare the effect of PSD502 with placebo on morphine requirements |
| Sources of funding | Plethora Solutions Limited (UK) |
| Trial website | |
| Publications | |
| Contact name | Miss Sheryl Caswell |
| Address |
Plethora Solutions
Lupus House 11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| sheryl.caswell@plethorasolutions.co.uk | |
| Sponsor | Plethora Solutions Ltd |
| Address |
Lupus House
11-13 macklin Street London WC2B 5NH |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)207 269 8630 |
| mail@plethorasolutions.co.uk | |
| Sponsor website: | http://www.plethorasolutions.co.uk/index.php |
| Date applied | 15/02/2007 |
| Last edited | 24/04/2007 |
| Date ISRCTN assigned | 20/04/2007 |
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