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
Phase 4
Completed
- Conditions
- gastro-oesofageal reflux diseasereflux10017947
- Registration Number
- NL-OMON41804
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in reflux disease questionnaire score and self-rated health<br /><br>(Objective 1) and per cent recruited patients (Objective 2) between trial<br /><br>arms. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Self-rated health (Objective 1), Quality of life as assessed by SF-12<br /><br>(Objective 1), Completion rate (Objective 2), User acceptance and usability<br /><br>(Objective 2) </p><br>