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ISRCTN
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ISRCTN40276556
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ClinicalTrials.gov identifier
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Public title
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Efficacy of domperidone and/or omeprazole in the treatment of gastroesophageal reflux (GOR) in children - a comparative study.
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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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N0264130004
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Study hypothesis
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To document the efficacy of domperidone and/or omeprazole in neurologically normal and abnormal children found to have significant GOR on oesophageal pH monitoring.
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Lay summary
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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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Gastro-oesophageal reflux disease (GORD)
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Participants - inclusion criteria
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Children under 16 with a reflux index >1
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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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01/03/2004
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Anticipated end date
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01/05/2006
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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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Not provided at time of registration
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Interventions
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Double blind placebo controlled prospective randomised controlled trial.
Randomised to:
A. Domperidone
B. Omeprazole
C. Combination of both
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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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United Bristol Healthcare NHS Trust
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Trial website
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Publications
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Contact name
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Prof
B K
Sandhu
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Address
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C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 928 3473
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Fax
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+44 (0)117 928 3524
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Email
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r&eoffice@ubht.swest.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - 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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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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08/12/2010
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Date ISRCTN assigned
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30/09/2004
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