Esomeprazole in PPI Failures - IMPROVE
Gastroesophageal Reflux Disease
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
Eligibility Criteria
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
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