On demand versus continuous use of omeprazole on reflux symptoms (3)
| ISRCTN | ISRCTN11976737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11976737 |
| EudraCT/CTIS number | 2014-001314-25 |
| Secondary identifying numbers | 18049 |
- Submission date
- 04/03/2015
- Registration date
- 05/03/2015
- Last edited
- 29/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Public
King's College Hospital
Division of Primary Care and Public Health Sciences
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational; Design type: Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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 objectives | 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(s) | 14/WM/1196 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Reflux symptoms; Timepoint(s): At recruitment and at 8 weeks follow up |
| Secondary outcome measures | N/A |
| Overall study start date | 14/03/2015 |
| Completion date | 31/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 700; UK Sample Size: 140 |
| Total final enrolment | 488 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/03/2015 |
| Date of final enrolment | 31/05/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
Sponsor information
University/education
-
Stockholm
171 77
Sweden
| email@notknown | |
| Website | http://ki.se |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at the American Gastroenterological association (AGA) conference | 01/05/2019 | 06/10/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
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.
