Healing of patients suffering from gastroesophageal reflux esophagitisgrade C-D according to Los Angeles classification after treatment with pantoprazole-magnesium dihydrate 80 mg o.d. in comparison topantoprazole-sodium sesquihydrate 40 mg o.d. over 4 or 8 weeks - Magnum II
- Conditions
- Gastroesophageal reflux esophagitisMedDRA version: 5.0Level: lltClassification code 10038263
- Registration Number
- EUCTR2004-000492-33-HU
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Outpatients of at least 18 years of age
- Endoscopically confirmed gastroesophageal reflux esophagitis (LA grade C-D)
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
Gastrointestinal diseases:
- Endoscopically confirmed gastroesophageal reflux esophagitis (LA grade A-B)
- 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
- Symptomatic GERD without any endoscopic findings
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Inflammatory bowel diseases
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