Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

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.