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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00325676 |
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.
Condition | Intervention | Phase |
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Gastroesophageal Reflux Disease |
Drug: Pantoprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Principal Investigator: | Werner Janssen, MD | 23569 Lübeck, Germany |
Study ID Numbers: | BY1023/M3-342 |
Study First Received: | May 12, 2006 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00325676 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
GERD Pantoprazole Complete Remission |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Pantoprazole Esophageal Diseases Gastroesophageal Reflux |
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |