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...
Date First Received: May 12, 2006
Last Updated: July 16, 2008
Verified by: ALTANA Pharma, June 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2006
Overall Status: Completed
Estimated Enrollment: 639
Brief Summary
Official Title: “CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Intervention(s) in this Clinical Trial
- Drug: Pantoprazole
Outcome Measures for this Clinical Trial
Primary Measures
- time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary Measures
- further efficacy criteria
- safety
Criteria for Participation in this Clinical Trial
Main 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: ALTANA Pharma
Overall Clinical Trial Officials and Contacts
Werner Janssen, MD Principal Investigator 23569 Lübeck, Germany
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00325676
Study ID Number: BY1023/M3-342
ClinicalTrials.gov Identifier: NCT00325676
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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