Condition category
Digestive System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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?
Karolinska Institute (Sweden)

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



Primary contact

Ms Ellen Wright


Contact details

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

Additional identifiers

EudraCT number

2014-001314-25 number

Protocol/serial number


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


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


Study design

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


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

Intervention type



Drug names

Primary outcome measure

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

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

Planned Sample Size: 700; UK Sample Size: 140

Total final enrolment


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


Recruitment end date



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
United Kingdom

Sponsor information


Karolinska Institute

Sponsor details

171 77

Sponsor type




Funder type


Funder name

European Commission

Alternative name(s)

European Union, EC, EU

Funding Body Type

government organisation

Funding Body Subtype

National government


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

Basic results (scientific)

Publication list

2019 results presented at the American Gastroenterological association (AGA) conference in (added 06/10/2020)

Publication citations

Additional files

Editorial Notes

29/10/2020: The Karolinska Institute has been added as the trial sponsor. 06/10/2020: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 3. King's College London has confirmed that it is not the sponsor and has therefore been removed from this section. 10/08/2020: No publications found. 09/08/2017: No publications found in PubMed, verifying study status with principal investigator.