Contact information
Type
Scientific
Primary contact
Dr Peter Isaacs
ORCID ID
Contact details
Gastroenterology Unit
Blackpool
Fylde & Wyre Hospitals NHS Trust
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
+44 01253 303614
dr.isaacs@bfwhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0301167004
Study information
Scientific title
Acronym
Study hypothesis
What is the influence of on demand PPI prescribing on success in lifestyle change after brief interventions in patients with reflux disease who are obese, cigarette smokers or alcohol abusers?
Ethics approval
Not provided at time of registration
Study design
Randomised 2 arm trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Digestive System: Reflux
Intervention
Randomised 2 arm trial: either continued on demand PPI after one month or self medication with antacids after one month.
This trial was stopped as it failed to get primary care support.
Intervention type
Drug
Phase
Not Specified
Drug names
Proton pump inhibitors
Primary outcome measures
Success in weight reduction, reduction in cigarette consumption, maintenance of safe limits of alcohol consumption.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/06/2005
Overall trial end date
22/07/2006
Reason abandoned
Lack of facilities
Eligibility
Participant inclusion criteria
1. >16 and <80 years
2. Obese with BMI >30 with heartburn
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 patients, 150 in each arm
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/06/2005
Recruitment end date
22/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gastroenterology Unit
Blackpool
FY3 8NR
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Blackpool Fylde & Wyre Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary