Condition category
Digestive System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes