Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)
Phase 4
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT00325676
- Lead Sponsor
- Takeda
- Brief Summary
The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 639
Inclusion Criteria
- Written informed consent
- Endoscopically confirmed GERD (Los Angeles classification A-D)
- Patients whose compliance is expected to be high with respect to the completion of the questionnaires
Main
Exclusion Criteria
- Other gastrointestinal diseases
- Severe concomitant diseases
- Proton pump inhibitors (PPIs) during last 14 days before start
- H2 receptor antagonists, prokinetics during last 7 days before study start
- Helicobacter pylori (H. pylori) eradication during last 28 days before study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
- Secondary Outcome Measures
Name Time Method further efficacy criteria safety
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇿🇦Somerset-West, South Africa