HECTOR: Health Change and the Treatment of Reflux - does the prescription of proton pump inhibitor on demand for minor reflux disease affect motivation to correct cigarette smoking, obesity, alcohol abuse and inactivity?
| ISRCTN | ISRCTN25745442 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25745442 |
| Secondary identifying numbers | N0301167004 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 11/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Isaacs
Scientific
Scientific
Gastroenterology Unit
Blackpool, Fylde & Wyre Hospitals NHS Trust
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
| Phone | +44 01253 303614 |
|---|---|
| dr.isaacs@bfwhospitals.nhs.uk |
Study information
| Study design | Randomised 2 arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Proton pump inhibitors |
| Primary outcome measure | 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 study start date | 22/06/2005 |
| Completion date | 22/07/2006 |
| Reason abandoned (if study stopped) | Lack of facilities |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 patients, 150 in each arm |
| Key inclusion criteria | 1. >16 and <80 years 2. Obese with BMI >30 with heartburn |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/06/2005 |
| Date of final enrolment | 22/07/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology Unit
Blackpool
FY3 8NR
United Kingdom
FY3 8NR
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Blackpool Fylde & Wyre Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
