Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs 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 symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.
When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination).
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks|
- complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.
- complete reflux disease remission rates after 4, 8, and 12 weeks
- time to reach first complete remission
- time to reach sustained complete remission
- time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
- average symptom load above pre-defined GERD symptoms threshold
- relief rates from reflux disease related complaints after 4, 8 and 12 weeks
- endoscopically confirmed healing rates after 4, 8, and 12 weeks
- symptom relief rates after 4, 8 and 12 weeks
- influence of the H. pylori status on the complete reflux disease remission rate
- influence of the H. pylori status on the symptom relief rates
- influence of the H. pylori status on the endoscopically confirmed healing rates.
|Study Start Date:||May 2005|
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|Study Chair:||Hartmut Heinze, MD||Altana Pharma AG, D-78467 Konstanz, Germany, email@example.com|