Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

• Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.

• Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics

• Use of antacids [except for study supplied Gelusil®]

• Need for continuous anticoagulant therapy (blood thinners)

• Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

• History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)

• Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.

• History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.

• Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy