Gastroesophageal Reflux Disease
Conditions
Brief summary
The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.
Interventions
DRUGEsomeprazole
DRUGOther PPI marketed in Sweden
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Male or female, aged 18-65 years * History of GERD symptoms during, at least, six months prior to enrolment * PPI as maintenance treatment during the last 30 days prior to enrolment * Heartburn as predominant GERD symptom, as judged by the investigator * Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)
Exclusion criteria
* Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer * Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm, * Gastric or duodenal ulcers within the last three months, Malabsorbtion * Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study * Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable * Patients with severe diseases or disorders which may interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients free from heartburn | — |
Secondary
| Measure | Time frame |
|---|---|
| Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire. | — |
| EuroQol 5D questionnaire. | — |
| Quality Assurance of GERD Treatment Questionnaire | — |
| Willingness to pay | — |
| Serious Adverse Events and Discontinuations due to Adverse Events | — |
Countries
Sweden
Outcome results
None listed