Condition category
Digestive System
Date applied
04/03/2015
Date assigned
05/03/2015
Last edited
05/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gastro-oesophageal reflux disease (GORD) refers to a range of disorders mainly caused by the backward flow of acid from the stomach into the oesophagus (gullet). Heartburn and acid regurgitation (a bitter burning taste at the back of the mouth) are the most typical symptoms of GORD. GORD is a chronic disease (prevalence 10-20 % in Europe) that has a detrimental effect on a person’s quality of life (QoL). It is mainly treated in primary care (for example, the GP surgery) with a proton pump inhibitor (PPI) once or twice a day, or on demand. There is conflicting data on which of these two treatment regimens is better and this lack of knowledge is likely to be related to the difficulties of performing large studies in primary care. In addition, patient reported outcomes such as symptom frequency and severity, QoL and self-rated health are important but are rarely used in primary care today. This study has been developed to answer the question “what gives most symptom relief and improvement in quality of life in patients with GORD, on demand or continuous use of proton pump inhibitors?”

Who can participate?
Adults aged between 18-65 years, diagnosed with GORD that responds to PPI treatment.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are treated with regular use of proton pump inhibitors. Those in group 2 are treated with on demand use of proton pump inhibitors. In this pilot study, the TRANSFoRm* tool is tested in 5 countries with 8 primary care practices each, including 20 patients per practice. The progress of each patient is followed for 8 weeks.
* TRANSFoRm is a project to develop tools to help in the running of clinical trials in primary care, including the collection of both care reported outcomes and patient reported outcomes . It also aims to develop a suite of software tools and underlying infrastructure to support primary and epidemiological research

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
King's College Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2015 to May 2015

Who is funding the study?
The European Commission (Belgium)

Who is the main contact?
Ms Ellen Wright

Trial website

Contact information

Type

Public

Primary contact

Ms Ellen Wright

ORCID ID

Contact details

King's College Hospital
Division of Primary Care and Public Health Sciences
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom

Additional identifiers

EudraCT number

2014-001314-25

ClinicalTrials.gov number

Protocol/serial number

18049

Study information

Scientific title

The effect of on demand versus continuous use of proton pump inhibitors on reflux symptoms, quality of life and self-rated health in patients with gastro-oesophageal reflux disease

Acronym

Study hypothesis

The aim of this study is to determine what gives most symptom relief and improvement in quality of life in patients with gastro-oesophageal reflux disease (GORD): on demand or continuous use of proton pump inhibitors

Ethics approval

14/WM/1196

Study design

Randomised; Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases

Intervention

Drug treatment
Regular versus on demand dosing of omeprazole for control control of reflux symptoms.

Intervention type

Drug

Phase

Drug names

Primary outcome measures

Reflux symptoms; Timepoint(s): At recruitment and at 8 weeks follow up

Secondary outcome measures

N/A

Overall trial start date

14/03/2015

Overall trial end date

31/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65 years
2. Predominant GORD cases with heartburn and/or acid regurgitation that need PPI treatment
3. PPI responsive
4. Ability to complete questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 700; UK Sample Size: 140

Participant exclusion criteria

1. Known Barrett’s oesophagus
2. Known severe oesophagitis (LA C or above)
3. Continuous use of NSAID/aspirin
4. Prophylactic PPI use to reduce the risk of ulcers in persons being treated with NSAIDs
5. PPI treatment to heal an ulcer induced by NSAID treatment in the last 6 months
6. PPI treatment for H. pylori eradication in the last 6 months
7. Severe disorders other than GORD with a negative impact on quality of life
8. Signs of upper gastrointestinal bleeding
9. Alarm symptoms: unintentional weight loss/vomiting/difficulties swallowing
10. Pregnancy

Recruitment start date

14/03/2015

Recruitment end date

31/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Division of Primary Care and Public Health Sciences Capital House 42 Weston Street
London
SE1 3QD
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Section for Specialist & Palliative Care Nursing
Florence Nightingale School of Nursing & Midwifery
150 Stamford Street
London
SE1 9NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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