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ISRCTN
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ISRCTN41155448
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ClinicalTrials.gov identifier
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Public title
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A Randomised, Double Blind, Placebo Controlled Study to Assess the Effects of Ranitidine on the Survival of Patients with Gastric Cancer
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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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RANM09
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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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Gastric Cancer
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Participants - inclusion criteria
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1. Aged <18 years
2. Gastric cancer proven by histology and endoscopy or barium meal
3. Patients selected for laparotomy must commence intravenous treatment with study drug at the time of induction of anaesthesia
4. Adequate renal function
5. No previous resection for gastric cancer
6. No other prior or concurrent malignancy
7. No treatment with systemic steroids, hormones or other know immunomodulating drugs within the last 7 days prior to the start of the study period
8. No medical contraindications to study treatments
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2001
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Anticipated end date
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31/12/2005
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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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1. Arm A: Ranitidine 50 mg in 20 ml 0.9% saline or 5% dextrose to be given intravenously three times daily until oral treatment is tolerated. This will be followed by ranitidine 150 mg tablet twice daily until death or for a period of 5 years.
2. Arm B: Placebo 50 mg in 20 ml 0.9% saline or 5% dextrose to be given intravenously three times daily until oral treatment is tolerated. This will be followed by placebo 150 mg tablet twice daily until death or for a period of 5 years.
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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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GlaxoSmithKline (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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Glaxo Wellcome (UK)
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Address
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Stockley Park West
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City/town
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Uxbridge, Middlesex
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Zip/Postcode
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UB11 1BT
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Country
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United Kingdom
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Tel
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+44(0) 20 8990 9000
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Fax
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+44(0) 20 8990 4321
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Email
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Sponsor website:
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http://uk.gsk.com
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Date applied
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19/08/2002
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Last edited
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19/05/2008
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Date ISRCTN assigned
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19/08/2002
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