EUCTR2004-004806-25-DE
Active, not recruiting
Not Applicable
Evaluation of the complete remission rates in patients with symptomatic non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD) treated with pantoprazole 40 mg o.d. over 4 or 8 or 12 weeks - Complete Remission
DrugsPantozol 40 mg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal reflux disease
- Sponsor
- ALTANA Pharma AG
- Enrollment
- 1200
- Status
- Active, not recruiting
- Last Updated
- 14 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
- •\- Reflux disease related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D according to LA\-classification
- •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
- •\- Pyloric stenosis
- •\- 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
Outcomes
Primary Outcomes
Not specified
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