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
- Conditions
- Gastrooesophageal reflux diseaseTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2014-001314-25-NL
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 700
* 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
* 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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