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
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 measure
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 (if study stopped)
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
Total final enrolment
488
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
Karolinska Institute
Sponsor details
-
Stockholm
171 77
Sweden
-
email@notknown
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Commission
Alternative name(s)
European Union, EC, EU
Funding Body Type
government organisation
Funding Body Subtype
National government
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
Basic results (scientific)
Publication list
2019 results presented at the American Gastroenterological association (AGA) conference in https://www.gastrojournal.org/article/S0016-5085(19)37030-1/fulltext (added 06/10/2020)