Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study

The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Inclusion Criteria:

• Had Gastro Esophageal Reflux disease with or without oesophagitis.
• Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.

Exclusion Criteria:

• History of surgery of stomach or oesophagus.
• Gastric ulcer (can be included after healing of gastric ulcer).
• Duodenal ulcer (can be included after healing of duodenal ulcer).
• Bleeding (melena, hematemesis).
• Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
• Barrett oesophagus with dysplasia.
• Complicated esophagitis (oesophageal strictures or ulcers).
• Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
• Pregnancy, wish to become pregnant, breast feeding.
• Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) > 100 mg/day.