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ISRCTN
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ISRCTN80154838
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DOI
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10.1186/ISRCTN80154838
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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DSP-2230 Capsaicin and UVB Challenge Study
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Scientific title
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A randomised, double-blind, placebo-controlled, 4-way crossover, 2-part study investigating the pharmacodynamic effect of DSP-2230 using the ID Capsaicin and UVB models in healthy male subjects, using pregabalin and ibuprofen lysine as positive controls.
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Acronym
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N/A
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Serial number at source
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D8450055
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Study hypothesis
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1. To determine the PD effects of DSP 2230 using the intradermal (ID) capsaicin model in healthy subjects
2. To determine the PD effects of DSP 2230 using the Ultraviolet B (UVB) model in healthy subjects
3. To assess the safety and tolerability of single doses of DSP 2230 in healthy subjects
4. To assess the single dose pharmacokinetics (PK) of DSP 2230 in healthy subjects
5. To assess the single dose PK/PD relationship of DSP 2230, if possible
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Lay summary
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Lay summary under review 2
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Ethics approval
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South East Wales Research Ethics Committee
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Study design
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Randomised double-blind double dummy placebo controlled single dose 4-way crossover design
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Peripheral Neuropathic Pain
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Participants - inclusion criteria
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All subjects (males) will be in good health aged 18 - 55 years with no evidence of systemic disease and be able to comply with all aspects of the protocol and able to give written informed consent to participate in the study.
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Participants - exclusion criteria
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All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological or other major disorders. They will not have, or have had a history of, drug or alcohol abuse and will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study and will not have donated or lost > 500 mL of blood or blood products in the 3 months preceding the start of dosing.
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Anticipated start date
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07/01/2013
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Anticipated end date
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30/04/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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A total of 56 subjects will be randomised into the study, 28 in Part 1 and 28 in Part 2, to ensure that 24 subjects complete each part.
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Interventions
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Part 1 - ID capsaicin model:
ID capsaicin 100mg administered ID in 100ml of solution.
Pregabalin 300 mg orally administered.
Pregabalin placebo orally administered.
The DSP-2230 placebo oral suspension.
Part 2 - UVB model:
An 800 mg dose ibuprofen (as ibuprofen lysine 342 mg, orally delivering a 200 mg dose of ibuprofen per tablet). Ibuprofen placebo orally administered.
The DSP-2230 placebo oral suspension.
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Primary outcome measure(s)
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Safety:
Parts 1 and 2: Adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiogram (ECG) and ECG time intervals, clinical chemistry, haematology and urinalysis including biomarkers of renal function.
Pharmacodynamic:
Part 1 - ID capsaicin model: Subjective rating of pain using a visual analogue scale (VAS), area of punctate hyperalgesia, area of brush-evoked allodynia, area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry.
Part 2 - UVB model: Heat pain detection threshold (HPDT), heat pain tolerance threshold (HPTT), area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry.
Pharmacokinetic:
Parts 1 and 2: Plasma single dose PK of DSP-2230 and its metabolite
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Dainippon Sumitomo Pharma Europe Ltd (UK)
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Trial website
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Publications
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Contact name
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Dr
Peter
Dewland
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Address
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ICON Development Solutions
Skelton House
Manchester Science Park
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City/town
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Manchester
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Zip/Postcode
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M15 6SH
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Country
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United Kingdom
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Sponsor
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Dainippon Sumitomo Pharma Europe Ltd (UK)
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Address
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c/o Ruth Rasbridge
First Floor
Southside
97-105 Victoria Street
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City/town
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London
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Zip/Postcode
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SW1E 6QT
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Country
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United Kingdom
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Sponsor website:
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http://www.dsp-e.com
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Date applied
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28/11/2012
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Last edited
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17/12/2012
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Date ISRCTN assigned
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17/12/2012
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