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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN34856269 |
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Date of registration:
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23/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A prospective randomised controlled trial of open access endoscopy and near patient testing for Helicobacter pylori antibodies in primary care
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Scientific title:
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Date of first enrolment:
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01/03/1995 |
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Target sample size:
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430 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN34856269 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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FDR
Hobbs |
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Address:
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The Department of Primary Care and General Practice
Medical School
University of Birmingham
Edgbaston
B15 2TT
Birmingham
United Kingdom |
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Telephone:
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+44 (0)121 414 3765 |
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Email:
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f.d.r.hobbs@bham.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Dyspeptic patients
2. Aged 18 years and over (either sex)
3. Helicobacter pylori positive
Exclusion criteria: 1. Previous endoscopy
2. Positive barium meal examination in the past three years
3. Unable to give informed consent
4. Unfit for endoscopy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Peptic ulcer disease
Digestive System
Gastro-oesophageal reflux disease
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Intervention(s)
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Under 50 years: Near patient testing for H. pylori (Helisal rapid blood, Cortecs diagnostics, UK) and open-access endoscopy if positive
Over 50 years: initial open access endoscopy
Controls: prescribing or specialist referral at GP's discretion
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Primary Outcome(s)
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Cost-effectiveness based on symptomatic improvement and health resource utilisation for dyspepsia at 12 months.
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Secondary Outcome(s)
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1. Quality of life (QoL)
2. Patient satisfaction
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Source(s) of Monetary Support
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NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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