Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
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.
Gastroesophageal Reflux Disease (GERD)
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints|
- Safety (adverse events, laboratory values). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Evaluation of gastrointestinal symptoms, histological parameters. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2000|
|Study Completion Date:||July 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Pantoprazole 40 mg
Long term Pantoprozole trial
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261300
|Hannover, Germany, 30659|
|Principal Investigator:||Gorig Brunner, Prof. Dr.||30659 Hannover, Germany|