Conditions: Gastroesophageal Reflux
Keywords: GERD Gastroesophageal Reflux Disease Drug Therapy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 506
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.

Interventions: intervention 1: Lansoprazole
Intervention descriptions: intervention 1: Lansoprazole capsules

Protocol document: