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ISRCTN
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ISRCTN96357650
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ClinicalTrials.gov identifier
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Public title
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A randomised phase II trial of the antiemetic effects of Nozinan® compared to a standard dexamethasone containing protocol
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0084096585
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Study hypothesis
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How does the antiemetic effects of dexamethasone and levomepromazine (Nozinan®) compare in the treatment of delayed emesis in patients receiving a cisplatin-based chemotherapy regimen (ECF)?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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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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Vomiting, delayed chemotherapy-induced emesis (DCIE)
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Participants - inclusion criteria
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196 Patients, 93 in each arm.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/09/2000
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Anticipated end date
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31/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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186
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Interventions
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Randomised controlled trial comparing (a) study treatment (ie Nozinan®) and (b) standard treatment (ie dexamethasone and Maxolon®).
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Primary outcome measure(s)
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Reduction in emesis.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Link Pharmaceuticals (UK)
2. NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Dr
Anthony
Maraveyas
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Address
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Department of Oncology
The Princess Royal Hospital
Salthouse Road
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City/town
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Hull
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Zip/Postcode
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HU8 9HE
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Country
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United Kingdom
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Email
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mdsam@doctors.org.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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21/10/2009
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Date ISRCTN assigned
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12/09/2003
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