Open, randomised, multi-center study of on demand versus continuous esomeprazole treatment in patient with GERD - NEED

Exclusion Criteria

• - Documented esophageal mucosal break
• - History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer
• - Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria:
• · Symptoms relieved by defecation
• · Symptoms associated with change in frequency of stools
• · Symptoms associated with change in form of stools
• - Any significant “alarm symptoms” such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.
• - Subjects with current or historical evidence of the following diseases/conditions
• · Zollinger Ellison syndrome
• · Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm
• · Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett’s metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus
• · Evidence of upper gastrointestinal malignancy at the screening endoscopy
• · Gastric and/or duodenal ulcers within the last 2 years
• · Malabsorption
• · Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator
• · Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable
• · Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus
• - Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy
• - Use of PPIs for more than 5 days in the last 7 days prior to endoscopy
• - Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study
• - Need for continuous concurrent therapy with
• · NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily for cardiovascular prophylaxis)
• · anticholinergics
• · prostaglandin analogues
• · phenytoin
• · ketoconazole
• · itraconazole
• · warfarin and other vitamin K antagonists
• - Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For South-Africa and Spain:
• Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)
• - Use of any other investigational compound 28 days prior to start and during the study
• - Requirement of an interpreter (illiterate)
• - Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator
• - Previous participation in this study
• - Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole