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ISRCTN
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ISRCTN76165153
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ClinicalTrials.gov identifier
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Public title
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A Multi-Centre, Randomised, Double Blind. Placebo Controlled Trial to Investigate the Effect of Bicalutamide (Casodex) 150mg on the Pharmacokinetics of Midazolam in Prostate Cancer Patients
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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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ZEN7054IL/29
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Study hypothesis
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Not provided at time of registration
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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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Prostate cancer
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Participants - inclusion criteria
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1. Histologically or cytologically confirmed prostate cancer
2. If surgically orchiectomised following 1 month depot of leutenizing hormone releasing hormone (LHRH) analogue therapy, at least 42 days must elapse from the end of the therapy before entry into the trial.
3. Adequate liver function
4. Not currently receiving drugs which may effect treatment
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Participants - exclusion criteria
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Patients are excluded if treated with 3 monthly LHRH analogue depots.
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Anticipated start date
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01/01/1997
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Anticipated end date
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06/02/1998
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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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Not provided at time of registration
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Interventions
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Patients are randomised to receive:
1. Treatment A: Bicalutamide 150 mg daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35.
2. Treatment B: Oral placebo daily for 35 days plus three oral doses of midazolam 7.5 mg on days 1, 10 and 35.
NB Active treatment Bicalutamide or placebo was only taken for 28 days (Day 8-35).
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Primary outcome measure(s)
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Not provided at time of registration
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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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AstraZeneca Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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AstraZeneca Clinical Research Group (UK)
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Address
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10 Logie Mill
Beaverbank Office Park
Lovie Green Road
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City/town
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Edinburgh
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Zip/Postcode
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EH7 4HG
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Country
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United Kingdom
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Sponsor website:
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http://www.astrazeneca.co.uk
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Date applied
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19/08/2002
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Last edited
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29/05/2008
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Date ISRCTN assigned
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19/08/2002
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