The effect of use of proton pump inhibitors on reflux (heartburn/acid) symptoms, quality of life and self-rated health in patients with reflux in primary care

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001314-25-NL

Enrollment

700

Registered

2014-07-21

Start date

2015-03-10

Completion date

Unknown

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrooesophageal reflux disease

Interventions

Trade Name: Omeprazole Product Name: omeprazole Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Age 18-65 years * Predominant GORD cases with heartburn and/or acid regurgitation that need PPI treatment * PPI responsive * Ability to complete questionnaires Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate whether there is a difference in symptom relief in patients prescribed PPI on demand and patients prescribed continuous use of PPI. 2. To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher recruitment rates than paper-based data collection. ;Secondary Objective: 1. To evaluate whether there is a difference in quality of life and self-rated health in patients prescribed PPI on demand and patients prescribed continuous use of PPI. 2. A) To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher completion rate than paper-based data collection. B) To evaluate the user acceptance and usability of the electronic tools in GPs and patients. ;Primary end point(s): Presence and frequency of reflux symptoms as assessed by RDQ (Objective 1) Recruitment rate (Objective 2) ;Timepoint(s) of evaluation of this end point: Week 8 (last visit for participant)	—

Measure

Time frame

Main Objective: 1. To evaluate whether there is a difference in symptom relief in patients prescribed PPI on demand and patients prescribed continuous use of PPI. 2. To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher recruitment rates than paper-based data collection. ;Secondary Objective: 1. To evaluate whether there is a difference in quality of life and self-rated health in patients prescribed PPI on demand and patients prescribed continuous use of PPI. 2. A) To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher completion rate than paper-based data collection. B) To evaluate the user acceptance and usability of the electronic tools in GPs and patients. ;Primary end point(s): Presence and frequency of reflux symptoms as assessed by RDQ (Objective 1) Recruitment rate (Objective 2) ;Timepoint(s) of evaluation of this end point: Week 8 (last visit for participant)

—

Secondary

Measure	Time frame
Secondary end point(s): Self-rated health (Objective 1) Quality of life as assessed by SF-12 (Objective 1) Completion rate (Objective 2) ;Timepoint(s) of evaluation of this end point: Week 8 (last visit for participant)	—

Countries

Netherlands

Contacts

Public ContactCentre for Family Medicine

Karolinska Institutet

villvetamer@cefam.se460852488000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 18, 2026