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ISRCTN
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ISRCTN95137574
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ClinicalTrials.gov identifier
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Public title
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Glyceryltrinitrate in the treatment of haemorrhoids
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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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RBF 97XX8
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Study hypothesis
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The proposed study will examine:
1. The physiology of anal canal mucosal blood flow and its relationship to pressures in the anal canal in patients with 1st and 2nd degree haemorrhoids compared to patients without disease
2. The effects of topical GTN formulations on anal canal pressure and its relationship to mucosal blood flow in the anal canal and in particular in 1st and 2nd degree haemorrhoids
3. The efficacy of treatment with GTN topical formulations compared to sclerotherapy or band ligation for 1st and 2nd degree haemorrhoids in a randomised trial
4. The delivery of topically applied GTN from novel formulations preparations and its optimisation
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Lay summary
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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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Haemorrhoids
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Participants - inclusion criteria
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200 patients with 1st or 2nd degree haemorrhoidal disease attending the colorectal unit outpatient clinic.
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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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01/09/1997
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Anticipated end date
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31/08/1998
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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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200
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Interventions
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Not provided at time of registration
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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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NHS Executive Trent (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12524411
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Contact name
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Mr
John
Scholefield
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Address
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Department of Surgery
University of Nottingham
E Floor
West Block
Queen's Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 970 9245
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Fax
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+44 (0)115 970 9428
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Email
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john.scholefield@nottingham.ac.uk
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Sponsor
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NHS R&D Regional Programme 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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23/01/2004
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Last edited
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16/11/2011
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Date ISRCTN assigned
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23/01/2004
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