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ISRCTN
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ISRCTN11557289
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ClinicalTrials.gov identifier
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Public title
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STOOL - Stepped Treatment of Older adults On Laxatives
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Scientific title
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Acronym
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STOOL
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Serial number at source
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HTA 98/32/99
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Study hypothesis
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1. To investigate the clinical and cost effectiveness of bulk forming, stimulant and osmotic laxatives prescribed by primary care to ambulant older people living at home.
2. To investigate the clinical and cost effectiveness of prescribing an additional second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent.
3. To describe the adherence by patients to treatment protocols.
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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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Pragmatic factorial randomised 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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Digestive system diseases: Other digestive system disease
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Participants - inclusion criteria
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People aged 55 or over with chronic constipation living in private households.
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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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01/10/2002
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Anticipated end date
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30/04/2006
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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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Different forms of stepped pharmacological treatment of constipation with economic evaluation. An add-on qualitative study of the meaning and experience of constipation to older people and the views of general practitioners
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Primary outcome measure(s)
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The primary clinical outcome is the reported number of bowel movements per week at the end of each step (6 and 10 weeks after randomisation) and at six months follow-up.
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Secondary outcome measure(s)
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Secondary clinical outcomes include the presence/absence of the other Rome criteria for constipation; adverse effects of treatment (although some of these may also be symptoms of constipation); and relapse rates. In addition to the measurement of these clinical outcomes, patient satisfaction and the impact of the treatment on costs and quality of life will be assessed
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.ncl.ac.uk/chsr/research/economics/project/709
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18462572
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Contact name
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Prof
John
Bond
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Address
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Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4AA
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Country
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United Kingdom
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Tel
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+44 (0)191 222 6777
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Fax
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+44 (0)191 222 6043
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Email
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john.bond@newcastle.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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14/05/2008
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Date ISRCTN assigned
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25/04/2003
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