Treatment response in patients with symptoms due to gastroesophageal reflux disease either with or without esophagitis treated with pantoprazole sodium 40 mg o.d. over 8 weeks. - Real Life Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

Written informed consent by the patient for study participation, prior to protocol specific procedures. Outpatients of at least 18 years of age 21 years in Argentina . Patient considered by the investigator to have symptoms due to gastroesophageal reflux disease. Patients whose compliance is expected to be high with respect to the completion of the questionnaires and diaries ReQuest , GERDyzer , HADS, TSS according to the assessment of the investigator.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Zollinger-Ellison syndrome or other gastric hypersecretory condition. Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract exception polypectomy and cholecystectomy . On initial endoscopy, presence of obstructive esophageal strictures, Schatzki s ring, esophageal diverticula, esophageal varices, achalasia or Barrett s esophagus with known high-grade dysplasia or longer than 3 cm. Acute peptic ulcer and/or ulcer complications. Inflammatory bowel diseases. Severe or unstable cardiovascular e.g., severe angina pectoris, postmyocardial infarction and ventricular extrasystoles , pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant. Malignant disease of any kind during the previous 5 years except for successfully treated skin basal or squamous cell cancer. Tendency to react allergically to drugs, especially with known hypersensitivity to one of the compounds of the study medication. Alcohol, drug or medication abuse within the past year. Clinically relevant abnormal laboratory values and vital signs suggesting an underlying disease and requiring further clinical evaluation. Severe psychiatric or neurologic disorders. Pregnant or nursing female patients. Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases Previous medication PPIs during the last 10 days before the start of the study. H2-receptor antagonists or prokinetics during the last 7 days before the start of the study. Any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study. Systemic glucocorticoids or non-steroidal anti-inflammatory drugs NSAIDs including COX-2-inhibitors 5 days on demand but not more than 3 consecutive days during the last 28 days before the start of the study except regular intake of acetylsalicylic acid in dosages up to 163 mg/d. Concomitant medication PPIs except study medication , H2-receptor antagonists, prokinetics, sucralfate, misoprostol, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms. Systemic glucocorticoids or non-steroidal anti-inflammatory drugs NSAIDs including COX-2-inhibitors 5 days on demand but not more than 3 consecutive days except regular intake of acetylsalicylic acid in dosages up to 163 mg/d. Ketoconazole or other drugs with pH-dependent absorption. PPIs in combination with antibiotics for the purpose of the eradication of H. pylori. Onset or change of psychotropic medication. Patients who are expected to be non-compliant and/or not co-operative. Participation in a clinical study within the last 30 days prior to the start of the study. Patients who have participated already in this study. Patients who are employees at the investigational site, relatives or spouse of the investigator. Any donation of germ cells, blood, organs, or bone marrow during the course of the study. Patients who are not contractually capable.

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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