GERD
Conditions
Keywords
Gastroesophageal reflux disease, Heartburn, Acid-related diseases, Acid reflux disease, Nexium
Brief summary
The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.
Interventions
DRUGEsomeprazole
PROCEDUREAmbulatory 24-hour esophageal pH-monitoring
Sponsors
UMC Utrecht
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Symptoms suggestive for gastric acid reflux disease during 2 or more days per week
Exclusion criteria
* Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion * Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion * History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms. | — |
| Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test. | — |
Countries
Netherlands
Outcome results
None listed