EUCTR2005-003485-42-BE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- gastroesophageal reflux disease
- Sponsor
- ALTANA Pharma AG
- Enrollment
- 2000
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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