EUCTR2004-000493-32-SK
Active, not recruiting
Phase 1
Healing of patients suffering from gastroesophageal reflux esophagitisgrade A-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
ConditionsGastroesophageal reflux esophagitisMedDRA version: 5.0Level: lltClassification code 10038263
DrugsCONTROLOC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Gastroesophageal reflux esophagitis
- Sponsor
- ALTANA Pharma AG
- Status
- Active, not recruiting
- Last Updated
- 4 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
- •\- Endoscopically confirmed gastroesophageal reflux esophagitis (LA grade A\-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
Exclusion Criteria
- •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
- •\- Symptomatic GERD without any endoscopic findings
- •\- Acute peptic ulcer and/or ulcer complications
- •\- Pyloric stenosis
- •\- Inflammatory bowel diseases
Outcomes
Primary Outcomes
Not specified
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