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 weeksRespuesta al tratamiento en pacientes con síntomas debidos a la enfermedad por reflujo gastroesofágico, con o sin esofagitis, tratados con 40 mg de pantoprazol sódico o.d. durante 8 semanas” - REAL LIFE

ALTANA Pharma AG0 sites2,000 target enrollmentMarch 13, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 13, 2006

End Date

August 14, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•Signs, indicating other gastrointestinal diseases:
•\- 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
•Other concomitant 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