Status:
COMPLETED
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Lead Sponsor:
Takeda
Conditions:
Esophagitis, Reflux
Esophagitis, Peptic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 subjec...
Detailed Description
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 m...
Eligibility Criteria
Inclusion
- Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
2038 Patients enrolled
Trial Details
Trial ID
NCT00251693
Start Date
December 1 2005
End Date
January 1 2007
Last Update
February 3 2012
Active Locations (140)
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1
Alabaster, Alabama, United States
2
Birmingham, Alabama, United States
3
Huntsville, Alabama, United States
4
Phoenix, Arizona, United States