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

Phase 2

Completed

• Conditions: Management of pain from donor sites in burns subjects undergoing skin grafts.; Skin and Connective Tissue Diseases; burns subjects undergoing skin grafts

• Registration Number: ISRCTN18863931
• Lead Sponsor: Plethora Solutions Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-20
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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 Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of PSD502 with placebo in relieving pain, as assessed by visual analogue pain scale (VAPS), from skin graft donor sites.

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the safety and tolerability of PSD502 applied to skin graft donor sites<br>2. To characterise the preliminary pharmacokinetics of PSD502<br>3. To evaluate and compare the effect of PSD502 with placebo on morphine requirements