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Sponsored by: |
ALTANA Pharma |
---|---|
Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00261300 |
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.
Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).
The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease (GERD) Peptic Ulcers |
Drug: Pantoprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints |
Estimated Enrollment: | 100 |
Study Start Date: | October 2000 |
Study Completion Date: | July 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Pantoprazole 40 mg
|
Drug: Pantoprazole
Long term Pantoprozole trial
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | BY1023/VMG-708 |
Study First Received: | December 2, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00261300 |
Health Authority: | Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) |
Gastric acid GERD Gastroesophageal reflux disease Pantoprazole Proton pump inhibitor |
Esophageal disorder Gastrointestinal Diseases Ulcer Pantoprazole Intestinal Diseases Gastroesophageal Reflux Esophageal Motility Disorders |
Deglutition Disorders Digestive System Diseases Stomach Diseases Esophageal Diseases Peptic Ulcer Duodenal Diseases |
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |